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Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With Stage III or Stage IV Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT00265941
Recruitment Status : Unknown
Verified April 2019 by Radiation Therapy Oncology Group.
Recruitment status was:  Active, not recruiting
First Posted : December 15, 2005
Results First Posted : December 21, 2017
Last Update Posted : December 30, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Head and Neck Cancer
Interventions Drug: cetuximab
Drug: cisplatin
Radiation: Accelerated Fractionation by Concomitant Boost
Radiation: Intensity-modulated radiation therapy
Enrollment 940
Recruitment Details  
Pre-assignment Details  
Arm/Group Title RT + Cisplatin RT + Cisplatin + Cetuximab
Hide Arm/Group Description Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
Period Title: Overall Study
Started 470 470
Completed 447 [1] 444 [1]
Not Completed 23 26
Reason Not Completed
Protocol Violation             22             25
Lost to Follow-up             1             1
[1]
Subjects with data available for the primary analysis are considered to have completed the study.
Arm/Group Title RT + Cisplatin RT + Cisplatin + Cetuximab Total
Hide Arm/Group Description Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab Total of all reporting groups
Overall Number of Baseline Participants 447 444 891
Hide Baseline Analysis Population Description
Eligible patients with follow-up
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 447 participants 444 participants 891 participants
57
(31 to 79)
58
(34 to 76)
57
(31 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 447 participants 444 participants 891 participants
Female
60
  13.4%
45
  10.1%
105
  11.8%
Male
387
  86.6%
399
  89.9%
786
  88.2%
1.Primary Outcome
Title Progression-free Survival (PFS) (3-year Rate Reported)
Hide Description Progression-free survival (PFS) is defined as time from randomization to date of local, regional, or distant disease progression, or death from any cause. Patients last known to be alive without progression are censored at the date of last contact. Three-year rates were estimated by the Kaplan-Meier method. Local or regional progression is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. Distant progression is defined as clear evidence of distant metastases.
Time Frame From randomization until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.)
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized eligible patients with follow-up data
Arm/Group Title RT + Cisplatin RT + Cisplatin + Cetuximab
Hide Arm/Group Description:
Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin
Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
Overall Number of Participants Analyzed 447 444
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
61.2
(56.7 to 65.8)
58.9
(54.2 to 63.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RT + Cisplatin, RT + Cisplatin + Cetuximab
Comments A total of 945 patients were required (900 analyzable) to test for a 25% reduction in the hazard associated with progression-free survival with 84% statistical power using a one-sided log-rank test at the 0.025 significance level (0.0238 after 3 interim analyses).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.76
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.88 to 1.32
Estimation Comments Reference arm = RT + cisplatin
2.Secondary Outcome
Title Overall Survival (OS) (3-year Rate Reported)
Hide Description Overall survival is defined as time from randomization to date of death from any cause. Patients last known to be alive are censored at the date of last contact. Three-year rates were estimated by the Kaplan-Meier method.
Time Frame From randomization until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.)
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized eligible patients with follow-up data
Arm/Group Title RT + Cisplatin RT + Cisplatin + Cetuximab
Hide Arm/Group Description:
Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin
Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
Overall Number of Participants Analyzed 447 444
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
72.9
(68.7 to 77.1)
75.8
(71.7 to 79.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RT + Cisplatin, RT + Cisplatin + Cetuximab
Comments Arms were compared using a one-sided log-rank test at the 0.025 significance level.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.32
Comments [Not Specified]
Method Log Rank
Comments One-sided log-rank significance level of 0.025
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.74 to 1.21
Estimation Comments Reference level = RT + cisplatin
3.Secondary Outcome
Title Local-regional Failure (LRF) (3-year Rate Reported)
Hide Description Local-regional failure is defined as time from randomization to date of failure (local or regional progression), or distant disease progression, or death from any cause. Patients last known to be alive without progression are censored at the date of last contact. Distant disease progression is considered a competing risk. Local or regional progression is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. Distant progression is defined as clear evidence of distant metastases. Three-year rates were estimated by the cumulative incidence method.
Time Frame From randomization until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.)
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized eligible patients with follow-up data
Arm/Group Title RT + Cisplatin RT + Cisplatin + Cetuximab
Hide Arm/Group Description:
Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin
Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
Overall Number of Participants Analyzed 447 444
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
19.9
(16.2 to 23.7)
25.9
(21.7 to 30.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RT + Cisplatin, RT + Cisplatin + Cetuximab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.97
Comments [Not Specified]
Method Log Rank
Comments One-sided significance level of 0.025
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
0.99 to 1.70
Estimation Comments Reference level = RT + cisplatin
4.Secondary Outcome
Title Rate of Mucositis Toxicity ≥ Grade 3
Hide Description Grade 3 or higher Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 radiation mucositis definitely, probably, or possibly related to protocol treatment. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
Time Frame From start of treatment until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.)
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized eligible patients with follow-up data
Arm/Group Title RT + Cisplatin RT + Cisplatin + Cetuximab
Hide Arm/Group Description:
Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin
Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
Overall Number of Participants Analyzed 447 444
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
33.3
(29.0 to 37.7)
43.2
(38.6 to 47.9)
5.Secondary Outcome
Title Rate of Other Toxicity ≥ Grade 3 (Not Mucositis)
Hide Description Grade 3 or higher Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 other than radiation mucositis definitely, probably, or possibly related to protocol treatment. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
Time Frame From start of treatment until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.)
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized eligible patients with follow-up data
Arm/Group Title RT + Cisplatin RT + Cisplatin + Cetuximab
Hide Arm/Group Description:
Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin
Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
Overall Number of Participants Analyzed 447 444
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
89.3
(86.4 to 92.1)
91.9
(89.4 to 94.4)
6.Secondary Outcome
Title Rate of Patients Who Tolerated Treatment
Hide Description A patient was considered to have tolerated treatment if radiation therapy was scored as per protocol or with acceptable variation, they received 2 cycles of cisplatin, and for arm 2, they received the initial dose of cetuximab and at least 5 weekly doses of cetuximab .
Time Frame From start of treatment to end of treatment (6-7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized eligible patients with follow-up data
Arm/Group Title RT + Cisplatin RT + Cisplatin + Cetuximab
Hide Arm/Group Description:
Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin
Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
Overall Number of Participants Analyzed 447 444
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
84.8
(81.5 to 88.1)
70.7
(66.5 to 75.0)
7.Secondary Outcome
Title Rate of Deaths ≤ 30 Days After Discontinuation of Protocol Treatment
Hide Description Patients who died during treatment or within 30 days after the end of treatment
Time Frame From start of treatment to 30 days after the end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized eligible patients with follow-up data
Arm/Group Title RT + Cisplatin RT + Cisplatin + Cetuximab
Hide Arm/Group Description:
Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin
Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
Overall Number of Participants Analyzed 447 444
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
1.8
(0.6 to 3.0)
2.0
(0.7 to 3.3)
8.Secondary Outcome
Title Quality of Life as Measured by European Quality of Life Questionnaire (EQ-5D)
Hide Description The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). Health states are defined by the combination of the leveled responses to the 5 dimensions, generating 243 health states to which unconsciousness and death are added. The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Both the 5-item index score and the VAS score are transformed into a utility score between 0 (worst health state) and 1 (best health state).
Time Frame 3 months and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized eligible patients with EQ-5D data at the given time point.
Arm/Group Title RT + Cisplatin RT + Cisplatin + Cetuximab
Hide Arm/Group Description:
Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin
Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
Overall Number of Participants Analyzed 447 444
Mean (Standard Deviation)
Unit of Measure: units on a scale
EQ-5D 3 months Number Analyzed 316 participants 289 participants
0.78  (0.18) 0.77  (0.15)
EQ-5D 12 months Number Analyzed 243 participants 253 participants
0.84  (0.17) 0.84  (0.16)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RT + Cisplatin, RT + Cisplatin + Cetuximab
Comments 3 months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.74
Comments [Not Specified]
Method Kolmogorov-Smirnov
Comments 2-sided significance level of 0.05
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection RT + Cisplatin, RT + Cisplatin + Cetuximab
Comments 12 months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments [Not Specified]
Method Kolmogorov-Smirnov
Comments 2-sided significance level of 0.05
9.Secondary Outcome
Title Quality of Life as Measured by Proportion of Patients With Performance Status Scale for Head and Neck Cancer (PSS-HN) Scores ≤ 50
Hide Description The PSS-HN is a clinician rated instrument consisting of assessment of three functions (subscales): Normalcy of Diet, Eating in Public, and Understandability of Speech. The interviewer rates the patient on each scale based on the patient's responses to targeted questions. Scores on each subscale range from 0-100, with higher scores indicating better performance. It has been demonstrated to be reliable and valid in head and neck cancer patients.The site research nurse or clinical research associate (CRA) will determine the score on each of the subscales by performing a clinical evaluation and unstructured interview format. The PSS-HN takes approximately 5 minutes to complete.
Time Frame 3 months and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized eligible patients with PSS-HN data at the given time point.
Arm/Group Title RT + Cisplatin RT + Cisplatin + Cetuximab
Hide Arm/Group Description:
Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin
Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
Overall Number of Participants Analyzed 447 444
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
Normalcy of Diet 3 months Number Analyzed 282 participants 272 participants
0.80
(0.75 to 0.84)
0.85
(0.80 to 0.89)
Normalcy of Diet 12 months Number Analyzed 234 participants 223 participants
0.37
(0.31 to 0.43)
0.37
(0.31 to 0.44)
Public Eating 3 months Number Analyzed 283 participants 272 participants
0.62
(0.56 to 0.67)
0.63
(0.59 to 0.67)
Public Eating 12 months Number Analyzed 234 participants 230 participants
0.18
(0.13 to 0.23)
0.23
(0.18 to 0.28)
Understandability of Speech 3 months Number Analyzed 294 participants 277 participants
0.09
(0.06 to 0.12)
0.08
(0.05 to 0.12)
Understandability of Speech 12 months Number Analyzed 238 participants 231 participants
0.05
(0.02 to 0.08)
0.04
(0.02 to 0.07)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RT + Cisplatin, RT + Cisplatin + Cetuximab
Comments Diet 3-month
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method Chi-squared
Comments 2-sided significance level of 0.05
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection RT + Cisplatin, RT + Cisplatin + Cetuximab
Comments Diet 12-month
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments [Not Specified]
Method Chi-squared
Comments 2-sided significance level 0.05
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection RT + Cisplatin, RT + Cisplatin + Cetuximab
Comments Eating 3-month
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments [Not Specified]
Method Chi-squared
Comments 2-sided significance level of 0.05
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection RT + Cisplatin, RT + Cisplatin + Cetuximab
Comments Eating 12-month
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method Chi-squared
Comments 2-sided significance level of 0.05
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection RT + Cisplatin, RT + Cisplatin + Cetuximab
Comments Speech 3-month
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.81
Comments [Not Specified]
Method Chi-squared
Comments 2-sided significance level of 0.05
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection RT + Cisplatin, RT + Cisplatin + Cetuximab
Comments Speech 12-month
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments [Not Specified]
Method Chi-squared
Comments 2-sided significance level of 0.05
10.Secondary Outcome
Title Quality of Life as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-HN) at 12 Months
Hide Description The Functional Assessment of Cancer Therapy-Head and Neck (FACT-HN) is a 10-item self-report instrument designed to measure multidimensional quality of life in patients with head and neck cancer. It is to be administered with the FACT-General. There are 5 responses options, with 0=Not a lot and 4=Very much. All items are added together to obtain a total score which ranges from 0-40. Certain items must be reversed before it is added by subtracting the response from 4. It requires at least 50% of the items to be completed while the overall response rate of the FACT-HN including the FACT-G must be greater than 80%. If items are missing, the subscale scores can be prorated. A higher score indicated better QOL. Change from baseline to 12 months (12 months - baseline) is reported.
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized eligible patients with baseline and 12-month FACT-HN data.
Arm/Group Title RT + Cisplatin RT + Cisplatin + Cetuximab
Hide Arm/Group Description:
Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin
Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
Overall Number of Participants Analyzed 229 226
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.41  (18.9) -5.11  (22.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RT + Cisplatin, RT + Cisplatin + Cetuximab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method t-test, 2 sided
Comments 2-sided significance level of 0.05
11.Secondary Outcome
Title Correlation of Expression of Epidermal Growth Factor Receptor (EGFR) With PFS, OS, and LRF
Hide Description EGFR expression is categorized as high (>/=80%) and low (<80%) in order to compare outcome by favorable and unfavorable risk group, per protocol. Times are measured from randomization. Overall survival is defined as time from randomization to date of death from any cause. PFS is time to loco-regional progression (LRP), distant disease progression (DDP), or death. LRF is time to LRP, DDP, or death, with DDP considered a competing risk. Patients last known to be alive without event are censored at the date of last contact. LRP is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. DDP is defined as clear evidence of distant metastases. Three-year LRF rates were estimated by the cumulative incidence method. Three-year PFS and OS rates were estimated by the Kaplan-Meier method.
Time Frame From randomization until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.)
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized eligible patients with follow-up and EGFR data.
Arm/Group Title Low EGFR High EGFR
Hide Arm/Group Description:
Less than 80% EGFR
Greater than or equal to 80% EGFR
Overall Number of Participants Analyzed 235 145
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Progression-free survival (PFS)
63.5
(56.9 to 69.4)
60.3
(51.7 to 67.8)
Overall survival (OS)
76.7
(70.6 to 81.7)
75.0
(66.9 to 81.4)
Loco-regional failure (LRF)
21.7
(16.6 to 27.3)
19.2
(13.1 to 26.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low EGFR, High EGFR
Comments Progression-free survival is compared between favorable risk and unfavorable risk groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.60
Comments [Not Specified]
Method Log Rank
Comments 2-sided significance level = 0.05
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.79 to 1.51
Estimation Comments Reference level = low EGFR
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Low EGFR, High EGFR
Comments Overall survival is compared between favorable risk and unfavorable risk groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.37
Comments [Not Specified]
Method Log Rank
Comments 2-sided significance level = 0.05
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
0.81 to 1.76
Estimation Comments Reference level = low EGFR
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Low EGFR, High EGFR
Comments Local-regional failure
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.76
Comments [Not Specified]
Method Log Rank
Comments 2-sided significance level = 0.05
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.60 to 1.46
Estimation Comments Reference level = low EGFR
12.Secondary Outcome
Title Correlation of Pre-treatment Positron Emission Tomography (PET)/CT Maximum Standardized Uptake Value (SUVmax) With PFS, OS, and LRF
Hide Description SUVmax is categorized as high (>median) and low (</=median). All times are measured from randomization. Overall survival is defined as time from randomization to date of death from any cause. PFS is time to loco-regional failure (LRP), distant disease progression (DDP), or death. LRF is time to LRP, DDP, or death, with DDP considered a competing risk. Patients last known to be alive without event are censored at the date of last contact. LRP is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. DDP is defined as clear evidence of distant metastases. Three-year LRF rates were estimated by the cumulative incidence method. Three-year PFS and OS rates were estimated by the Kaplan-Meier method.
Time Frame From randomization until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.)
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized eligible N2-3 patients with follow-up and PET data
Arm/Group Title Low PET SUVmax High PET SUVmax
Hide Arm/Group Description:
Less than or equal to median pretreatment PET SUVmax
Greater than median pretreatment PET SUVmax
Overall Number of Participants Analyzed 34 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Progression-free Survival (PFS)
55.9
(37.8 to 70.6)
85.3
(68.2 to 93.6)
Overall Survival (OS)
85.3
(68.2 to 93.6)
91.2
(75.1 to 97.1)
Loco-regional failure (LRF)
32.4
(17.4 to 48.3)
11.8
(3.6 to 25.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low PET SUVmax, High PET SUVmax
Comments Progression-free survival is compared between low and high SUVmax groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Log Rank
Comments 2-sided significance level = 0.05
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.30
Confidence Interval (2-Sided) 95%
0.12 to 0.75
Estimation Comments Reference level = low
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Low PET SUVmax, High PET SUVmax
Comments Overall survival (OS) is compared between low and high SUVmax groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method Log Rank
Comments 2-sided significance level = 0.05
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.38
Confidence Interval (2-Sided) 95%
0.12 to 1.20
Estimation Comments Reference level = low
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Low PET SUVmax, High PET SUVmax
Comments Loco-regional control (LRC) is compared between low and high SUVmax groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Log Rank
Comments 2-sided significance level = 0.05
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.31
Confidence Interval (2-Sided) 95%
0.10 to 0.97
Estimation Comments Reference level = low
13.Secondary Outcome
Title 2-year Nodal Relapse Rates in Clinical N2-3 Patients by Post-treatment PET/CT Finding and Nodal Response
Hide Description Patients are grouped by the combination of clinical nodal response status and the post-treatment PET/CT finding (negative or positive). Nodal relapse rate is calculated for each group by the cumulative incidence method. Relapse is defined as reappearance of tumor after complete response. If possible, relapse should be confirmed by biopsy.
Time Frame From randomization to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized eligible N2-3 patients with follow-up and PET data
Arm/Group Title Clinical CR + Negative PET No Clinical CR + Negative PET Clinical CR + Positive PET No Clinical CR + Positive PET
Hide Arm/Group Description:
Clinical nodal complete response; negative post-treatment PET/CT scan
Did not have clinical nodal complete response; negative post-treatment PET/CT scan
Clinical nodal complete response; positive post-treatment PET/CT scan
No clinical nodal complete response; positive post-treatment PET/CT scan
Overall Number of Participants Analyzed 26 15 12 9
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
3.9
(0 to 11.4)
33.3
(8.4 to 58.3)
16.7
(0 to 38.8)
11.1
(0 to 33.1)
Time Frame [Not Specified]
Adverse Event Reporting Description Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
 
Arm/Group Title RT + Cisplatin RT + Cisplatin + Cetuximab
Hide Arm/Group Description Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
All-Cause Mortality
RT + Cisplatin RT + Cisplatin + Cetuximab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
RT + Cisplatin RT + Cisplatin + Cetuximab
Affected / at Risk (%) Affected / at Risk (%)
Total   208/447 (46.53%)   237/444 (53.38%) 
Blood and lymphatic system disorders     
Blood/bone marrow - Other * 1  1/447 (0.22%)  2/444 (0.45%) 
Febrile neutropenia * 1  31/447 (6.94%)  24/444 (5.41%) 
Hemoglobin * 1  24/447 (5.37%)  32/444 (7.21%) 
Hemolysis NOS * 1  0/447 (0.00%)  2/444 (0.45%) 
Cardiac disorders     
Arrhythmia NOS * 1  0/447 (0.00%)  1/444 (0.23%) 
Atrial fibrillation * 1  2/447 (0.45%)  1/444 (0.23%) 
Atrial flutter * 1  1/447 (0.22%)  1/444 (0.23%) 
Cardiac general - Other * 1  0/447 (0.00%)  1/444 (0.23%) 
Cor pulmonale NOS * 1  1/447 (0.22%)  0/444 (0.00%) 
Left ventricular failure * 1  1/447 (0.22%)  2/444 (0.45%) 
Myocardial ischemia * 1  3/447 (0.67%)  5/444 (1.13%) 
Sinus arrhythmia * 1  0/447 (0.00%)  1/444 (0.23%) 
Sinus bradycardia * 1  1/447 (0.22%)  0/444 (0.00%) 
Ventricular tachycardia * 1  1/447 (0.22%)  0/444 (0.00%) 
Ear and labyrinth disorders     
Hearing impaired  1  2/447 (0.45%)  1/444 (0.23%) 
Otitis externa NOS * 1  1/447 (0.22%)  0/444 (0.00%) 
Pain: External ear * 1  1/447 (0.22%)  0/444 (0.00%) 
Tinnitus * 1  2/447 (0.45%)  0/444 (0.00%) 
Endocrine disorders     
Endocrine - Other * 1  1/447 (0.22%)  0/444 (0.00%) 
Gastrointestinal disorders     
Abdominal distention * 1  1/447 (0.22%)  0/444 (0.00%) 
Abdominal pain NOS * 1  3/447 (0.67%)  8/444 (1.80%) 
Constipation * 1  10/447 (2.24%)  14/444 (3.15%) 
Diarrhea NOS * 1  7/447 (1.57%)  14/444 (3.15%) 
Dry mouth * 1  5/447 (1.12%)  9/444 (2.03%) 
Duodenal perforation * 1  0/447 (0.00%)  1/444 (0.23%) 
Dysphagia  1  51/447 (11.41%)  46/444 (10.36%) 
Enteritis necroticans * 1  1/447 (0.22%)  0/444 (0.00%) 
Esophageal pain * 1  1/447 (0.22%)  3/444 (0.68%) 
Esophageal perforation * 1  1/447 (0.22%)  0/444 (0.00%) 
Esophageal stenosis acquired * 1  1/447 (0.22%)  0/444 (0.00%) 
Esophagitis NOS * 1  4/447 (0.89%)  7/444 (1.58%) 
Fistula, GI: Abdomen NOS * 1  0/447 (0.00%)  1/444 (0.23%) 
Fistula, GI: Oral cavity * 1  1/447 (0.22%)  0/444 (0.00%) 
Fistula, Pulmonary/upper respiratory: Oral cavity * 1  0/447 (0.00%)  1/444 (0.23%) 
Gastric hemorrhage * 1  0/447 (0.00%)  2/444 (0.45%) 
Gastric ulcer * 1  2/447 (0.45%)  0/444 (0.00%) 
Gastritis NOS * 1  0/447 (0.00%)  1/444 (0.23%) 
Gastrointestinal - Other * 1  2/447 (0.45%)  3/444 (0.68%) 
Hemorrhage, GI: Upper GI NOS * 1  1/447 (0.22%)  0/444 (0.00%) 
Hemorrhoids * 1  1/447 (0.22%)  0/444 (0.00%) 
Intra-abdominal hemorrhage NOS * 1  0/447 (0.00%)  1/444 (0.23%) 
Lower gastrointestinal hemorrhage * 1  1/447 (0.22%)  0/444 (0.00%) 
Malabsorption * 1  1/447 (0.22%)  0/444 (0.00%) 
Mucositis/stomatitis (clinical exam): Anus * 1  2/447 (0.45%)  0/444 (0.00%) 
Mucositis/stomatitis (functional/symptomatic): Esophagus * 1  0/447 (0.00%)  1/444 (0.23%) 
Nausea * 1  36/447 (8.05%)  59/444 (13.29%) 
Oral pain * 1  16/447 (3.58%)  18/444 (4.05%) 
Pancreatitis NOS * 1  1/447 (0.22%)  0/444 (0.00%) 
Radiation mucositis  1  28/447 (6.26%)  52/444 (11.71%) 
Rectal perforation * 1  0/447 (0.00%)  1/444 (0.23%) 
Rectal ulcer * 1  0/447 (0.00%)  1/444 (0.23%) 
Salivary gland disorder NOS * 1  2/447 (0.45%)  5/444 (1.13%) 
Small intestinal stricture NOS * 1  0/447 (0.00%)  1/444 (0.23%) 
Stomatitis * 1  4/447 (0.89%)  5/444 (1.13%) 
Tooth disorder NOS * 1  1/447 (0.22%)  0/444 (0.00%) 
Vomiting NOS * 1  31/447 (6.94%)  45/444 (10.14%) 
General disorders     
Chest pain * 1  1/447 (0.22%)  2/444 (0.45%) 
Constitutional Symptoms - Other * 1  3/447 (0.67%)  0/444 (0.00%) 
Death NOS * 1  1/447 (0.22%)  3/444 (0.68%) 
Disease progression NOS * 1  0/447 (0.00%)  1/444 (0.23%) 
Edema: head and neck * 1  2/447 (0.45%)  0/444 (0.00%) 
Edema: limb * 1  0/447 (0.00%)  2/444 (0.45%) 
Edema: trunk/genital * 1  0/447 (0.00%)  1/444 (0.23%) 
Facial pain * 1  1/447 (0.22%)  2/444 (0.45%) 
Fatigue * 1  8/447 (1.79%)  27/444 (6.08%) 
Multi-organ failure * 1  0/447 (0.00%)  3/444 (0.68%) 
Pain - Other * 1  4/447 (0.89%)  2/444 (0.45%) 
Pain NOS * 1  1/447 (0.22%)  0/444 (0.00%) 
Pyrexia * 1  12/447 (2.68%)  28/444 (6.31%) 
Rigors * 1  4/447 (0.89%)  4/444 (0.90%) 
Sudden death * 1  2/447 (0.45%)  2/444 (0.45%) 
Hepatobiliary disorders     
Gallbladder obstruction * 1  0/447 (0.00%)  1/444 (0.23%) 
Hepatic failure * 1  1/447 (0.22%)  0/444 (0.00%) 
Immune system disorders     
Cytokine release syndrome * 1  0/447 (0.00%)  1/444 (0.23%) 
Hypersensitivity NOS * 1  0/447 (0.00%)  15/444 (3.38%) 
Infections and infestations     
Abdominal infection * 1  0/447 (0.00%)  2/444 (0.45%) 
Ano-rectal infection NOS * 1  1/447 (0.22%)  0/444 (0.00%) 
Bladder infection NOS * 1  2/447 (0.45%)  1/444 (0.23%) 
Bone infection NOS * 1  2/447 (0.45%)  1/444 (0.23%) 
Bronchitis NOS * 1  0/447 (0.00%)  1/444 (0.23%) 
Gingival infection * 1  1/447 (0.22%)  1/444 (0.23%) 
Implant site infection * 1  2/447 (0.45%)  0/444 (0.00%) 
Infection - Other * 1  2/447 (0.45%)  5/444 (1.13%) 
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Abdomen NOS * 1  1/447 (0.22%)  2/444 (0.45%) 
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Bladder (urinary) * 1  1/447 (0.22%)  1/444 (0.23%) 
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Blood * 1  1/447 (0.22%)  3/444 (0.68%) 
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Bone (osteomyelitis) * 1  1/447 (0.22%)  0/444 (0.00%) 
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Brain + Spinal cord (encephalomyelitis) * 1  0/447 (0.00%)  1/444 (0.23%) 
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Catheter-related * 1  3/447 (0.67%)  1/444 (0.23%) 
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Dental-tooth * 1  0/447 (0.00%)  1/444 (0.23%) 
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Esophagus * 1  1/447 (0.22%)  0/444 (0.00%) 
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Foreign body (e.g., graft, implant, pro * 1  1/447 (0.22%)  0/444 (0.00%) 
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Lung (pneumonia) * 1  2/447 (0.45%)  1/444 (0.23%) 
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Middle ear (otitis media) * 1  1/447 (0.22%)  0/444 (0.00%) 
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Mucosa * 1  1/447 (0.22%)  0/444 (0.00%) 
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Nose * 1  1/447 (0.22%)  0/444 (0.00%) 
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Oral cavity-gums (gingivitis) * 1  0/447 (0.00%)  1/444 (0.23%) 
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Pancreas * 1  1/447 (0.22%)  0/444 (0.00%) 
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Stomach * 1  0/447 (0.00%)  1/444 (0.23%) 
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Trachea * 1  0/447 (0.00%)  1/444 (0.23%) 
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Wound * 1  3/447 (0.67%)  0/444 (0.00%) 
Infection with normal ANC or Grade 1 or 2 neutrophils: Blood * 1  3/447 (0.67%)  6/444 (1.35%) 
Infection with normal ANC or Grade 1 or 2 neutrophils: Catheter-related * 1  0/447 (0.00%)  3/444 (0.68%) 
Infection with normal ANC or Grade 1 or 2 neutrophils: Esophagus * 1  1/447 (0.22%)  0/444 (0.00%) 
Infection with normal ANC or Grade 1 or 2 neutrophils: Larynx * 1  1/447 (0.22%)  0/444 (0.00%) 
Infection with normal ANC or Grade 1 or 2 neutrophils: Lip/perioral * 1  0/447 (0.00%)  1/444 (0.23%) 
Infection with normal ANC or Grade 1 or 2 neutrophils: Neck NOS * 1  1/447 (0.22%)  0/444 (0.00%) 
Infection with normal ANC or Grade 1 or 2 neutrophils: Salivary gland * 1  1/447 (0.22%)  0/444 (0.00%) 
Infection with normal ANC or Grade 1 or 2 neutrophils: Wound * 1  1/447 (0.22%)  1/444 (0.23%) 
Infection with unknown ANC: Lung (pneumonia) * 1  1/447 (0.22%)  3/444 (0.68%) 
Infection with unknown ANC: Trachea * 1  1/447 (0.22%)  0/444 (0.00%) 
Nasopharyngitis * 1  2/447 (0.45%)  0/444 (0.00%) 
Opportunisitic infection * 1  1/447 (0.22%)  4/444 (0.90%) 
Otitis media NOS * 1  1/447 (0.22%)  0/444 (0.00%) 
Peritoneal infection * 1  1/447 (0.22%)  0/444 (0.00%) 
Pharyngitis * 1  1/447 (0.22%)  0/444 (0.00%) 
Pneumonia NOS * 1  11/447 (2.46%)  6/444 (1.35%) 
Respiratory tract infection NOS * 1  1/447 (0.22%)  1/444 (0.23%) 
Sepsis NOS * 1  2/447 (0.45%)  2/444 (0.45%) 
Skin infection * 1  2/447 (0.45%)  7/444 (1.58%) 
Urinary tract infection NOS * 1  2/447 (0.45%)  1/444 (0.23%) 
Wound infection * 1  0/447 (0.00%)  1/444 (0.23%) 
Injury, poisoning and procedural complications     
Burn * 1  1/447 (0.22%)  0/444 (0.00%) 
Culture wound negative * 1  1/447 (0.22%)  1/444 (0.23%) 
Dermatitis radiation NOS  1  5/447 (1.12%)  4/444 (0.90%) 
Hemorrhage, Pulmonary/upper respiratory: Trachea * 1  1/447 (0.22%)  0/444 (0.00%) 
Radiation recall syndrome  1  2/447 (0.45%)  17/444 (3.83%) 
Tracheal stenosis * 1  0/447 (0.00%)  2/444 (0.45%) 
Vascular access NOS complication * 1  3/447 (0.67%)  2/444 (0.45%) 
Vessel injury-artery: Carotid * 1  2/447 (0.45%)  0/444 (0.00%) 
Investigations     
Activated partial thromboplastin time prolonged * 1  0/447 (0.00%)  1/444 (0.23%) 
Alanine aminotransferase increased * 1  3/447 (0.67%)  6/444 (1.35%) 
Aspartate aminotransferase increased * 1  3/447 (0.67%)  6/444 (1.35%) 
Blood alkaline phosphatase increased * 1  1/447 (0.22%)  3/444 (0.68%) 
Blood amylase increased * 1  1/447 (0.22%)  1/444 (0.23%) 
Blood bilirubin increased * 1  1/447 (0.22%)  5/444 (1.13%) 
Blood creatine phosphokinase increased * 1  0/447 (0.00%)  1/444 (0.23%) 
Blood creatinine increased * 1  20/447 (4.47%)  19/444 (4.28%) 
Coagulopathy * 1  1/447 (0.22%)  1/444 (0.23%) 
Gamma-glutamyltransferase increased * 1  1/447 (0.22%)  0/444 (0.00%) 
Inappropriate antidiuretic hormone secretion * 1  1/447 (0.22%)  1/444 (0.23%) 
Leukopenia NOS * 1  34/447 (7.61%)  38/444 (8.56%) 
Lipase increased * 1  1/447 (0.22%)  0/444 (0.00%) 
Lymphopenia * 1  10/447 (2.24%)  26/444 (5.86%) 
Metabolic/laboratory - Other * 1  0/447 (0.00%)  3/444 (0.68%) 
Neutrophil count * 1  31/447 (6.94%)  34/444 (7.66%) 
Platelet count decreased * 1  7/447 (1.57%)  13/444 (2.93%) 
Prothrombin time prolonged * 1  1/447 (0.22%)  0/444 (0.00%) 
Troponin I increased * 1  3/447 (0.67%)  2/444 (0.45%) 
Troponin T increased * 1  0/447 (0.00%)  1/444 (0.23%) 
Weight decreased * 1  21/447 (4.70%)  18/444 (4.05%) 
Metabolism and nutrition disorders     
Anorexia * 1  12/447 (2.68%)  17/444 (3.83%) 
Blood iron increased * 1  1/447 (0.22%)  0/444 (0.00%) 
Dehydration * 1  68/447 (15.21%)  80/444 (18.02%) 
Hypercalcemia * 1  2/447 (0.45%)  0/444 (0.00%) 
Hyperglycemia NOS * 1  8/447 (1.79%)  10/444 (2.25%) 
Hyperkalemia * 1  4/447 (0.89%)  4/444 (0.90%) 
Hypermagnesemia * 1  1/447 (0.22%)  0/444 (0.00%) 
Hypernatremia * 1  2/447 (0.45%)  3/444 (0.68%) 
Hyperuricemia * 1  2/447 (0.45%)  0/444 (0.00%) 
Hypoalbuminemia * 1  10/447 (2.24%)  17/444 (3.83%) 
Hypocalcemia * 1  7/447 (1.57%)  16/444 (3.60%) 
Hypoglycemia NOS * 1  2/447 (0.45%)  1/444 (0.23%) 
Hypokalemia * 1  11/447 (2.46%)  25/444 (5.63%) 
Hypomagnesemia * 1  5/447 (1.12%)  18/444 (4.05%) 
Hyponatremia * 1  15/447 (3.36%)  32/444 (7.21%) 
Hypophosphatemia * 1  1/447 (0.22%)  6/444 (1.35%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  1/447 (0.22%)  0/444 (0.00%) 
Chest wall pain * 1  0/447 (0.00%)  1/444 (0.23%) 
Muscle weakness NOS * 1  2/447 (0.45%)  2/444 (0.45%) 
Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-lower * 1  1/447 (0.22%)  0/444 (0.00%) 
Neck pain * 1  1/447 (0.22%)  3/444 (0.68%) 
Osteonecrosis  1  7/447 (1.57%)  2/444 (0.45%) 
Pain in extremity * 1  0/447 (0.00%)  2/444 (0.45%) 
Soft tissue necrosis: Head  1  1/447 (0.22%)  2/444 (0.45%) 
Soft tissue necrosis: Neck  1  2/447 (0.45%)  1/444 (0.23%) 
Trismus * 1  0/447 (0.00%)  1/444 (0.23%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Secondary Malignancy - possibly related to cancer treatment * 1  0/447 (0.00%)  1/444 (0.23%) 
Nervous system disorders     
Cerebral ischemia * 1  2/447 (0.45%)  2/444 (0.45%) 
Cognitive disorder * 1  0/447 (0.00%)  1/444 (0.23%) 
Convulsions NOS * 1  0/447 (0.00%)  2/444 (0.45%) 
Depressed level of consciousness * 1  6/447 (1.34%)  1/444 (0.23%) 
Dizziness * 1  2/447 (0.45%)  3/444 (0.68%) 
Dysgeusia * 1  1/447 (0.22%)  4/444 (0.90%) 
Headache * 1  0/447 (0.00%)  2/444 (0.45%) 
Hemorrhagic stroke * 1  0/447 (0.00%)  2/444 (0.45%) 
Memory impairment * 1  1/447 (0.22%)  1/444 (0.23%) 
Mental status changes * 1  0/447 (0.00%)  2/444 (0.45%) 
Neuralgia NOS  1  5/447 (1.12%)  0/444 (0.00%) 
Neurology - Other * 1  1/447 (0.22%)  1/444 (0.23%) 
Peripheral motor neuropathy * 1  2/447 (0.45%)  0/444 (0.00%) 
Peripheral sensory neuropathy  1  3/447 (0.67%)  1/444 (0.23%) 
Speech disorder * 1  1/447 (0.22%)  0/444 (0.00%) 
Syncope * 1  1/447 (0.22%)  4/444 (0.90%) 
Syncope vasovagal * 1  0/447 (0.00%)  1/444 (0.23%) 
Psychiatric disorders     
Agitation * 1  0/447 (0.00%)  1/444 (0.23%) 
Anxiety * 1  1/447 (0.22%)  0/444 (0.00%) 
Confusional state * 1  5/447 (1.12%)  7/444 (1.58%) 
Depression * 1  0/447 (0.00%)  4/444 (0.90%) 
Insomnia * 1  1/447 (0.22%)  1/444 (0.23%) 
Psychosis aggravated * 1  0/447 (0.00%)  1/444 (0.23%) 
Renal and urinary disorders     
Bladder obstruction * 1  1/447 (0.22%)  0/444 (0.00%) 
Glomerular filtration rate * 1  1/447 (0.22%)  0/444 (0.00%) 
Renal failure NOS * 1  17/447 (3.80%)  12/444 (2.70%) 
Renal/genitourinary - Other * 1  1/447 (0.22%)  1/444 (0.23%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome * 1  0/447 (0.00%)  2/444 (0.45%) 
Aspiration * 1  4/447 (0.89%)  2/444 (0.45%) 
Cough * 1  7/447 (1.57%)  5/444 (1.13%) 
Dyspnea * 1  15/447 (3.36%)  8/444 (1.80%) 
Epistaxis * 1  0/447 (0.00%)  2/444 (0.45%) 
Hemorrhage, Pulmonary/upper respiratory: Bronchopulmonary NOS * 1  0/447 (0.00%)  1/444 (0.23%) 
Hemorrhage, Pulmonary/upper respiratory: Pharynx * 1  2/447 (0.45%)  3/444 (0.68%) 
Hiccups * 1  0/447 (0.00%)  1/444 (0.23%) 
Hypoxia * 1  4/447 (0.89%)  6/444 (1.35%) 
Laryngeal discomfort * 1  1/447 (0.22%)  0/444 (0.00%) 
Laryngeal edema  1  10/447 (2.24%)  4/444 (0.90%) 
Laryngeal stensos * 1  2/447 (0.45%)  1/444 (0.23%) 
Laryngitis NOS * 1  1/447 (0.22%)  2/444 (0.45%) 
Mucositis/stomatitis (clinical exam): Larynx  1  1/447 (0.22%)  2/444 (0.45%) 
Mucositis/stomatitis (clinical exam): Pharynx  1  11/447 (2.46%)  12/444 (2.70%) 
Mucositis/stomatitis (functional/symptomatic): Larynx * 1  3/447 (0.67%)  0/444 (0.00%) 
Mucositis/stomatitis (functional/symptomatic): Pharynx * 1  1/447 (0.22%)  2/444 (0.45%) 
Nasal cavity/paranasal sinus reactions * 1  0/447 (0.00%)  1/444 (0.23%) 
Obstruction/stenosis of airway: Pharynx * 1  1/447 (0.22%)  1/444 (0.23%) 
Pharyngeal fistula * 1  0/447 (0.00%)  1/444 (0.23%) 
Pharyngolaryngeal pain * 1  12/447 (2.68%)  9/444 (2.03%) 
Pleural effusion * 1  0/447 (0.00%)  2/444 (0.45%) 
Pneumonitis NOS * 1  2/447 (0.45%)  6/444 (1.35%) 
Pneumothorax NOS * 1  1/447 (0.22%)  0/444 (0.00%) 
Pulmonary/upper respiratory - Other * 1  2/447 (0.45%)  0/444 (0.00%) 
Skin and subcutaneous tissue disorders     
Acne NOS  1  0/447 (0.00%)  11/444 (2.48%) 
Alopecia * 1  1/447 (0.22%)  0/444 (0.00%) 
Decubitus ulcer * 1  1/447 (0.22%)  0/444 (0.00%) 
Dermatitis exfoliative NOS  1  2/447 (0.45%)  10/444 (2.25%) 
Dermatology/skin - Other  1  1/447 (0.22%)  3/444 (0.68%) 
Dry skin * 1  0/447 (0.00%)  2/444 (0.45%) 
Nail disorder NOS  1  0/447 (0.00%)  1/444 (0.23%) 
Pain of skin * 1  0/447 (0.00%)  3/444 (0.68%) 
Pruritus  1  0/447 (0.00%)  2/444 (0.45%) 
Skin atrophy * 1  1/447 (0.22%)  0/444 (0.00%) 
Skin fibrosis  1  3/447 (0.67%)  2/444 (0.45%) 
Skin hyperpigmentation * 1  1/447 (0.22%)  0/444 (0.00%) 
Telangiectasia * 1  1/447 (0.22%)  0/444 (0.00%) 
Ulceration * 1  1/447 (0.22%)  1/444 (0.23%) 
Vascular disorders     
Hemorrhage/bleeding - Other * 1  1/447 (0.22%)  2/444 (0.45%) 
Hypertension NOS * 1  0/447 (0.00%)  1/444 (0.23%) 
Hypotension NOS * 1  9/447 (2.01%)  16/444 (3.60%) 
Peripheral ischemia * 1  1/447 (0.22%)  0/444 (0.00%) 
Thrombosis * 1  4/447 (0.89%)  8/444 (1.80%) 
Vascular - Other * 1  2/447 (0.45%)  0/444 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
RT + Cisplatin RT + Cisplatin + Cetuximab
Affected / at Risk (%) Affected / at Risk (%)
Total   442/447 (98.88%)   433/444 (97.52%) 
Blood and lymphatic system disorders     
Blood/bone marrow - Other * 1  31/447 (6.94%)  31/444 (6.98%) 
Hemoglobin * 1  262/447 (58.61%)  250/444 (56.31%) 
Ear and labyrinth disorders     
Ear pain * 1  35/447 (7.83%)  33/444 (7.43%) 
Hearing impaired  1  127/447 (28.41%)  114/444 (25.68%) 
Tinnitus * 1  117/447 (26.17%)  106/444 (23.87%) 
Endocrine disorders     
Hypothyroidism * 1  82/447 (18.34%)  70/444 (15.77%) 
Gastrointestinal disorders     
Abdominal pain NOS * 1  25/447 (5.59%)  32/444 (7.21%) 
Constipation * 1  170/447 (38.03%)  146/444 (32.88%) 
Diarrhea NOS * 1  76/447 (17.00%)  92/444 (20.72%) 
Dry mouth * 1  352/447 (78.75%)  344/444 (77.48%) 
Dyspepsia * 1  52/447 (11.63%)  50/444 (11.26%) 
Dysphagia  1  431/447 (96.42%)  415/444 (93.47%) 
Esophageal stenosis acquired * 1  28/447 (6.26%)  35/444 (7.88%) 
Esophagitis NOS * 1  19/447 (4.25%)  26/444 (5.86%) 
Gastrointestinal - Other * 1  55/447 (12.30%)  51/444 (11.49%) 
Nausea * 1  252/447 (56.38%)  243/444 (54.73%) 
Oral pain * 1  143/447 (31.99%)  158/444 (35.59%) 
Radiation mucositis  1  349/447 (78.08%)  364/444 (81.98%) 
Salivary gland disorder NOS * 1  179/447 (40.04%)  159/444 (35.81%) 
Tooth disorder NOS * 1  39/447 (8.72%)  33/444 (7.43%) 
Vomiting NOS * 1  170/447 (38.03%)  179/444 (40.32%) 
General disorders     
Edema: head and neck * 1  119/447 (26.62%)  117/444 (26.35%) 
Edema: limb * 1  23/447 (5.15%)  19/444 (4.28%) 
Fatigue * 1  323/447 (72.26%)  316/444 (71.17%) 
Pain - Other * 1  64/447 (14.32%)  69/444 (15.54%) 
Pain NOS * 1  27/447 (6.04%)  28/444 (6.31%) 
Pyrexia * 1  56/447 (12.53%)  73/444 (16.44%) 
Rigors * 1  18/447 (4.03%)  30/444 (6.76%) 
Infections and infestations     
Gingival infection * 1  25/447 (5.59%)  23/444 (5.18%) 
Infection - Other * 1  21/447 (4.70%)  38/444 (8.56%) 
Injury, poisoning and procedural complications     
Dermatitis radiation NOS  1  264/447 (59.06%)  229/444 (51.58%) 
Radiation recall syndrome  1  129/447 (28.86%)  200/444 (45.05%) 
Investigations     
Alanine aminotransferase increased * 1  85/447 (19.02%)  96/444 (21.62%) 
Aspartate aminotransferase increased * 1  71/447 (15.88%)  69/444 (15.54%) 
Blood alkaline phosphatase increased * 1  48/447 (10.74%)  34/444 (7.66%) 
Blood bilirubin increased * 1  17/447 (3.80%)  38/444 (8.56%) 
Blood creatinine increased * 1  108/447 (24.16%)  81/444 (18.24%) 
Leukopenia NOS * 1  207/447 (46.31%)  206/444 (46.40%) 
Lymphopenia * 1  98/447 (21.92%)  87/444 (19.59%) 
Metabolic/laboratory - Other * 1  46/447 (10.29%)  46/444 (10.36%) 
Neutrophil count * 1  134/447 (29.98%)  124/444 (27.93%) 
Platelet count decreased * 1  100/447 (22.37%)  108/444 (24.32%) 
Weight decreased * 1  253/447 (56.60%)  263/444 (59.23%) 
Metabolism and nutrition disorders     
Anorexia * 1  163/447 (36.47%)  160/444 (36.04%) 
Dehydration * 1  118/447 (26.40%)  104/444 (23.42%) 
Hyperglycemia NOS * 1  149/447 (33.33%)  170/444 (38.29%) 
Hyperkalemia * 1  40/447 (8.95%)  46/444 (10.36%) 
Hypermagnesemia * 1  29/447 (6.49%)  17/444 (3.83%) 
Hypoalbuminemia * 1  127/447 (28.41%)  137/444 (30.86%) 
Hypocalcemia * 1  90/447 (20.13%)  116/444 (26.13%) 
Hypokalemia * 1  84/447 (18.79%)  102/444 (22.97%) 
Hypomagnesemia * 1  106/447 (23.71%)  152/444 (34.23%) 
Hyponatremia * 1  165/447 (36.91%)  186/444 (41.89%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  28/447 (6.26%)  20/444 (4.50%) 
Fibrosis-deep connective tissue * 1  23/447 (5.15%)  21/444 (4.73%) 
Muscle weakness NOS * 1  23/447 (5.15%)  31/444 (6.98%) 
Musculoskeletal/soft tissue - Other * 1  33/447 (7.38%)  48/444 (10.81%) 
Neck pain * 1  80/447 (17.90%)  96/444 (21.62%) 
Osteonecrosis  1  46/447 (10.29%)  44/444 (9.91%) 
Trismus * 1  97/447 (21.70%)  99/444 (22.30%) 
Nervous system disorders     
Dizziness * 1  43/447 (9.62%)  55/444 (12.39%) 
Dysgeusia * 1  245/447 (54.81%)  240/444 (54.05%) 
Headache * 1  56/447 (12.53%)  83/444 (18.69%) 
Neuralgia NOS  1  94/447 (21.03%)  87/444 (19.59%) 
Peripheral motor neuropathy * 1  21/447 (4.70%)  29/444 (6.53%) 
Peripheral sensory neuropathy  1  110/447 (24.61%)  121/444 (27.25%) 
Psychiatric disorders     
Anxiety * 1  64/447 (14.32%)  48/444 (10.81%) 
Depression * 1  64/447 (14.32%)  62/444 (13.96%) 
Insomnia * 1  68/447 (15.21%)  72/444 (16.22%) 
Respiratory, thoracic and mediastinal disorders     
Aspiration * 1  31/447 (6.94%)  28/444 (6.31%) 
Cough * 1  110/447 (24.61%)  94/444 (21.17%) 
Dyspnea * 1  60/447 (13.42%)  65/444 (14.64%) 
Hiccups * 1  24/447 (5.37%)  20/444 (4.50%) 
Laryngeal discomfort * 1  23/447 (5.15%)  13/444 (2.93%) 
Laryngeal edema  1  209/447 (46.76%)  200/444 (45.05%) 
Laryngitis NOS * 1  177/447 (39.60%)  152/444 (34.23%) 
Mucositis/stomatitis (clinical exam): Larynx  1  85/447 (19.02%)  74/444 (16.67%) 
Mucositis/stomatitis (clinical exam): Pharynx  1  240/447 (53.69%)  218/444 (49.10%) 
Pharyngolaryngeal pain * 1  185/447 (41.39%)  154/444 (34.68%) 
Pulmonary/upper respiratory - Other * 1  47/447 (10.51%)  36/444 (8.11%) 
Skin and subcutaneous tissue disorders     
Acne NOS  1  13/447 (2.91%)  291/444 (65.54%) 
Alopecia * 1  94/447 (21.03%)  90/444 (20.27%) 
Dermatitis exfoliative NOS  1  58/447 (12.98%)  206/444 (46.40%) 
Dermatology/skin - Other  1  150/447 (33.56%)  158/444 (35.59%) 
Dry skin * 1  26/447 (5.82%)  36/444 (8.11%) 
Pruritus  1  34/447 (7.61%)  153/444 (34.46%) 
Skin fibrosis  1  220/447 (49.22%)  213/444 (47.97%) 
Skin hyperpigmentation * 1  94/447 (21.03%)  87/444 (19.59%) 
Skin hypopigmentation * 1  26/447 (5.82%)  28/444 (6.31%) 
Telangiectasia * 1  37/447 (8.28%)  32/444 (7.21%) 
Vascular disorders     
Hypotension NOS * 1  31/447 (6.94%)  39/444 (8.78%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Wendy Seiferheld, M.S.
Organization: NRG Oncology
EMail: seiferheldw@nrgoncology.org
Publications of Results:
Layout table for additonal information
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00265941    
Other Study ID Numbers: RTOG 0522
CDR0000458049
NCI-2009-00729 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: December 14, 2005
First Posted: December 15, 2005
Results First Submitted: September 26, 2017
Results First Posted: December 21, 2017
Last Update Posted: December 30, 2019