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Bevacizumab, Cisplatin, Radiation Therapy, and Fluorouracil in Treating Patients With Stage IIB, Stage III, Stage IVA, or Stage IVB Nasopharyngeal Cancer

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ClinicalTrials.gov Identifier: NCT00408694
Recruitment Status : Completed
First Posted : December 7, 2006
Results First Posted : April 18, 2013
Last Update Posted : January 30, 2018
Sponsor:
Collaborator:
Radiation Therapy Oncology Group
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Stage II Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7
Stage III Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7
Stage III Nasopharyngeal Undifferentiated Carcinoma AJCC v7
Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7
Stage IV Nasopharyngeal Undifferentiated Carcinoma AJCC v7
Interventions Radiation: 3-Dimensional Conformal Radiation Therapy
Biological: Bevacizumab
Drug: Cisplatin
Drug: Fluorouracil
Radiation: Intensity-Modulated Radiation Therapy
Enrollment 46
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)
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BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.

ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Period Title: Overall Study
Started 46
Completed 44 [1]
Not Completed 2
Reason Not Completed
Ineligible             1
No protocol treatment             1
[1]
Subjects contributing data to the primary analysis are considered to have completed the study.
Arm/Group Title Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)
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BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.

ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Overall Number of Baseline Participants 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 46 participants
48
(18 to 63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
Female
16
  34.8%
Male
30
  65.2%
1.Primary Outcome
Title Percentage of Patients With a Grade 4 Hemorrhage or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment During the First Year.
Hide Description Estimated using a binomial distribution along with the 95% confidence interval. Adverse events (AE) are graded using CTCAE v3.0. 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 to one year.
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Hide Analysis Population Description
Eligible patients who started study treatment.
Arm/Group Title Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)
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BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.

ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)
Comments Null hypothesis, H0: Incidence of patients with either grade 4 hemorrhage or any grade 5 adverse event for the protocol treatment regimen ≤ 0.05. Alternative hypothesis, HA: Incidence of patients with either grade 4 hemorrhage or any grade 5 adverse event for the protocol treatment regimen ≥ 0.15.
Type of Statistical Test Other
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Patients With Grade 4 Hemorrhage or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment After the First Year.
Hide Description Estimated using a binomial distribution along with the 95% confidence interval. Adverse events (AE) are graded using CTCAE v3.0. 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 Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from day 366 to death or study termination whichever occurs first, up to 3.6 years.
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Hide Analysis Population Description
Eligible patients who started study treatment and survived more than one year.
Arm/Group Title Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)
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BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.

ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 41
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 0)
3.Secondary Outcome
Title Patient Tolerability to Each Component (Concurrent and Adjuvant) of the Protocol Treatment Regimen
Hide Description Evaluated in terms of protocol treatment delivery. For concurrent treatment, measured by the percentage of patients who received 2 or more cycles of cisplatin (CDDP) and bevacizumab (BV) during concurrent treatment with radiation therapy(RT) and who had RT scored by the study chair as no variation or minor variation. For adjuvant treatment, measured by the percentage of patients who received 2 or more cycles of CDDP and 5-FU and BV during the adjuvant treatment phase. Estimated using a binomial distribution along with their associated 95% confidence intervals.
Time Frame From start of treatment to end of treatment (approximately day 109).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)
Hide Arm/Group Description:

BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.

ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Concurrent component
68.2
(52.4 to 81.4)
Adjuvant component
68.2
(52.4 to 81.4)
4.Secondary Outcome
Title Death During or Within 30 Days of Discontinuation of Protocol Treatment.
Hide Description The percentage of patients dying during protocol treatment or within 30 days after the end of treatment. Estimated using a binomial distribution along with associated 95% confidence interval.
Time Frame From start of treatment to 30 days after end of treatment (treatment ends approximately day 109).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)
Hide Arm/Group Description:

BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.

ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 0)
5.Secondary Outcome
Title One- and Two-year Distant Metastases-free Rates
Hide Description Distant metastasis is defined as clear evidence of distant metastases (lung, bone, brain, etc.); biopsy is recommended where possible. Distant metastasis-free rate estimated by cumulative incidence method with death considered a competing risk.
Time Frame From registration to two years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)
Hide Arm/Group Description:

BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.

ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
One-year
97.7
(93.3 to 100.0)
Two-year
90.8
(82.2 to 99.5)
6.Secondary Outcome
Title One- and Two-year Loco-regional Progression-free Rates
Hide Description Loco-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. Local-regional progression-free rate estimated by cumulative incidence with death considered a competing risk.
Time Frame Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from study registration to death or study termination whichever occurs first, up to 3.6 years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment.
Arm/Group Title Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)
Hide Arm/Group Description:

BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.

ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
One-year
93.2
(85.6 to 100.0)
Two-year
74.7
(61.8 to 87.6)
7.Secondary Outcome
Title One- and Two-year Progression-free Survival Rates
Hide Description Progression-free survival rate estimated by Kaplan-Meier method along with 95% confidence interval. An event is loco-regional or distant progression, or death due to any cause. Loco-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 distant metastases.
Time Frame Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from study registration to death or study termination whichever occurs first, up to 3.6 years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)
Hide Arm/Group Description:

BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.

ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
One-year
90.9
(82.4 to 99.4)
Two-year
74.7
(61.8 to 87.6)
8.Secondary Outcome
Title One- and Two-year Overall Survival Rates
Hide Description Overall survival rate estimated by Kaplan-Meier method along with 95% confidence interval. An event is death due to any cause.
Time Frame Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from study registration to death or study termination whichever occurs first, up to 3.6 years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)
Hide Arm/Group Description:

BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.

ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
One-year
93.2
(85.7 to 100.0)
Two-year
90.9
(82.3 to 99.4)
9.Secondary Outcome
Title Percentage of Patients With Other Grade 3-5 Adverse Events Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment
Hide Description Estimated using a binomial distribution along with the 95% confidence interval. Adverse events (AE) are graded using CTCAE v3.0. 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 Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from start of treatment to death or study termination whichever occurs first, up to 3.6 years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started treatment
Arm/Group Title Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)
Hide Arm/Group Description:

BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.

ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
90.9
(78.3 to 97.5)
Time Frame [Not Specified]
Adverse Event Reporting Description Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
 
Arm/Group Title Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)
Hide Arm/Group Description

BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.

ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Data is reported for eligible patients with adverse event data who started study treatment, which is 44 patients.

All-Cause Mortality
Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)
Affected / at Risk (%)
Total   28/44 (63.64%) 
Blood and lymphatic system disorders   
Anemia * 1  2/44 (4.55%) 
Febrile neutropenia * 1  2/44 (4.55%) 
Cardiac disorders   
Paroxysmal atrial tachycardia * 1  1/44 (2.27%) 
Sinus tachycardia * 1  1/44 (2.27%) 
Ear and labyrinth disorders   
Hearing impaired * 1  3/44 (6.82%) 
Eye disorders   
Conjunctivitis * 1  1/44 (2.27%) 
Gastrointestinal disorders   
Abdominal pain * 1  2/44 (4.55%) 
Constipation * 1  2/44 (4.55%) 
Diarrhea * 1  3/44 (6.82%) 
Dysphagia * 1  6/44 (13.64%) 
Gastrointestinal disorders - Other * 1  1/44 (2.27%) 
Lower gastrointestinal hemorrhage * 1  1/44 (2.27%) 
Mucositis oral * 1  10/44 (22.73%) 
Nausea * 1  7/44 (15.91%) 
Oral pain * 1  2/44 (4.55%) 
Rectal fistula * 1  1/44 (2.27%) 
Upper gastrointestinal hemorrhage * 1  1/44 (2.27%) 
Vomiting * 1  7/44 (15.91%) 
General disorders   
Chills * 1  1/44 (2.27%) 
Fatigue * 1  5/44 (11.36%) 
Fever * 1  3/44 (6.82%) 
General disorders and administration site conditions - Other * 1  1/44 (2.27%) 
Infections and infestations   
Catheter related infection * 1  1/44 (2.27%) 
Infections and infestations - Other * 1  5/44 (11.36%) 
Lung infection * 1  1/44 (2.27%) 
Penile infection * 1  1/44 (2.27%) 
Peripheral nerve infection * 1  1/44 (2.27%) 
Sinusitis * 1  1/44 (2.27%) 
Injury, poisoning and procedural complications   
Dermatitis radiation * 1  1/44 (2.27%) 
Investigations   
Alanine aminotransferase increased * 1  2/44 (4.55%) 
Aspartate aminotransferase increased * 1  2/44 (4.55%) 
Blood antidiuretic hormone abnormal * 1  1/44 (2.27%) 
Lymphocyte count decreased * 1  2/44 (4.55%) 
Neutrophil count decreased * 1  6/44 (13.64%) 
Platelet count decreased * 1  4/44 (9.09%) 
Weight loss * 1  2/44 (4.55%) 
White blood cell decreased * 1  5/44 (11.36%) 
Metabolism and nutrition disorders   
Acidosis * 1  1/44 (2.27%) 
Anorexia * 1  2/44 (4.55%) 
Dehydration * 1  9/44 (20.45%) 
Hyperglycemia * 1  1/44 (2.27%) 
Hypernatremia * 1  1/44 (2.27%) 
Hypokalemia * 1  1/44 (2.27%) 
Hyponatremia * 1  3/44 (6.82%) 
Hypophosphatemia * 1  1/44 (2.27%) 
Musculoskeletal and connective tissue disorders   
Chest wall pain * 1  1/44 (2.27%) 
Musculoskeletal and connective tissue disorder - Other * 1  1/44 (2.27%) 
Nervous system disorders   
Depressed level of consciousness * 1  3/44 (6.82%) 
Dysgeusia * 1  1/44 (2.27%) 
Neuralgia * 1  1/44 (2.27%) 
Psychiatric disorders   
Depression * 1  4/44 (9.09%) 
Reproductive system and breast disorders   
Erectile dysfunction * 1  1/44 (2.27%) 
Respiratory, thoracic and mediastinal disorders   
Aspiration * 1  1/44 (2.27%) 
Cough * 1  2/44 (4.55%) 
Dyspnea * 1  1/44 (2.27%) 
Epistaxis * 1  1/44 (2.27%) 
Laryngeal mucositis * 1  1/44 (2.27%) 
Pharyngeal mucositis * 1  3/44 (6.82%) 
Pharyngolaryngeal pain * 1  3/44 (6.82%) 
Vascular disorders   
Hypertension * 1  3/44 (6.82%) 
Thromboembolic event * 1  1/44 (2.27%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)
Affected / at Risk (%)
Total   44/44 (100.00%) 
Blood and lymphatic system disorders   
Anemia * 1  18/44 (40.91%) 
Blood and lymphatic system disorders - Other * 1  1/44 (2.27%) 
Febrile neutropenia * 1  1/44 (2.27%) 
Hemolysis * 1  2/44 (4.55%) 
Cardiac disorders   
Paroxysmal atrial tachycardia * 1  1/44 (2.27%) 
Sinus bradycardia * 1  1/44 (2.27%) 
Ear and labyrinth disorders   
Ear and labyrinth disorders - Other * 1  1/44 (2.27%) 
Ear pain * 1  2/44 (4.55%) 
External ear inflammation * 1  1/44 (2.27%) 
Hearing impaired * 1  20/44 (45.45%) 
Middle ear inflammation * 1  1/44 (2.27%) 
Tinnitus * 1  14/44 (31.82%) 
Endocrine disorders   
Hyperthyroidism * 1  1/44 (2.27%) 
Hypothyroidism * 1  4/44 (9.09%) 
Eye disorders   
Blurred vision * 1  1/44 (2.27%) 
Eye disorders - Other * 1  1/44 (2.27%) 
Photophobia * 1  1/44 (2.27%) 
Gastrointestinal disorders   
Abdominal pain * 1  1/44 (2.27%) 
Anal mucositis * 1  1/44 (2.27%) 
Constipation * 1  22/44 (50.00%) 
Dental caries * 1  4/44 (9.09%) 
Diarrhea * 1  10/44 (22.73%) 
Dry mouth * 1  42/44 (95.45%) 
Dyspepsia * 1  4/44 (9.09%) 
Dysphagia * 1  42/44 (95.45%) 
Esophageal pain * 1  1/44 (2.27%) 
Esophagitis * 1  2/44 (4.55%) 
Gastritis * 1  2/44 (4.55%) 
Gastrointestinal disorders - Other * 1  3/44 (6.82%) 
Lip pain * 1  1/44 (2.27%) 
Lower gastrointestinal hemorrhage * 1  1/44 (2.27%) 
Mucositis oral * 1  40/44 (90.91%) 
Nausea * 1  32/44 (72.73%) 
Oral pain * 1  14/44 (31.82%) 
Rectal fistula * 1  1/44 (2.27%) 
Rectal pain * 1  1/44 (2.27%) 
Toothache * 1  1/44 (2.27%) 
Upper gastrointestinal hemorrhage * 1  2/44 (4.55%) 
Vomiting * 1  21/44 (47.73%) 
General disorders   
Chills * 1  4/44 (9.09%) 
Edema face * 1  10/44 (22.73%) 
Edema limbs * 1  2/44 (4.55%) 
Fatigue * 1  35/44 (79.55%) 
Fever * 1  11/44 (25.00%) 
General disorders and administration site conditions - Other * 1  2/44 (4.55%) 
Pain * 1  9/44 (20.45%) 
Immune system disorders   
Allergic reaction * 1  1/44 (2.27%) 
Infections and infestations   
Gum infection * 1  4/44 (9.09%) 
Infections and infestations - Other * 1  8/44 (18.18%) 
Lung infection * 1  2/44 (4.55%) 
Peripheral nerve infection * 1  1/44 (2.27%) 
Pharyngitis * 1  1/44 (2.27%) 
Sinusitis * 1  2/44 (4.55%) 
Upper respiratory infection * 1  1/44 (2.27%) 
Urinary tract infection * 1  1/44 (2.27%) 
Wound infection * 1  1/44 (2.27%) 
Injury, poisoning and procedural complications   
Bruising * 1  1/44 (2.27%) 
Dermatitis radiation * 1  22/44 (50.00%) 
Radiation recall reaction (dermatologic) * 1  20/44 (45.45%) 
Investigations   
Activated partial thromboplastin time prolonged * 1  2/44 (4.55%) 
Alanine aminotransferase increased * 1  5/44 (11.36%) 
Alkaline phosphatase increased * 1  5/44 (11.36%) 
Aspartate aminotransferase increased * 1  5/44 (11.36%) 
Blood bilirubin increased * 1  3/44 (6.82%) 
Creatinine increased * 1  7/44 (15.91%) 
GGT increased * 1  1/44 (2.27%) 
INR increased * 1  2/44 (4.55%) 
Investigations - Other * 1  4/44 (9.09%) 
Lymphocyte count decreased * 1  9/44 (20.45%) 
Neutrophil count decreased * 1  14/44 (31.82%) 
Platelet count decreased * 1  13/44 (29.55%) 
Weight loss * 1  19/44 (43.18%) 
White blood cell decreased * 1  17/44 (38.64%) 
Metabolism and nutrition disorders   
Acidosis * 1  2/44 (4.55%) 
Anorexia * 1  12/44 (27.27%) 
Dehydration * 1  10/44 (22.73%) 
Hyperglycemia * 1  14/44 (31.82%) 
Hypernatremia * 1  1/44 (2.27%) 
Hypertriglyceridemia * 1  1/44 (2.27%) 
Hypoalbuminemia * 1  14/44 (31.82%) 
Hypocalcemia * 1  7/44 (15.91%) 
Hypokalemia * 1  9/44 (20.45%) 
Hypomagnesemia * 1  10/44 (22.73%) 
Hyponatremia * 1  15/44 (34.09%) 
Hypophosphatemia * 1  3/44 (6.82%) 
Musculoskeletal and connective tissue disorders   
Avascular necrosis * 1  3/44 (6.82%) 
Generalized muscle weakness * 1  2/44 (4.55%) 
Joint range of motion decreased * 1  1/44 (2.27%) 
Muscle weakness lower limb * 1  1/44 (2.27%) 
Musculoskeletal and connective tissue disorder - Other * 1  1/44 (2.27%) 
Myalgia * 1  2/44 (4.55%) 
Neck pain * 1  4/44 (9.09%) 
Pain in extremity * 1  2/44 (4.55%) 
Trismus * 1  15/44 (34.09%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumor pain * 1  1/44 (2.27%) 
Nervous system disorders   
Accessory nerve disorder * 1  1/44 (2.27%) 
Acoustic nerve disorder NOS * 1  1/44 (2.27%) 
Cognitive disturbance * 1  1/44 (2.27%) 
Depressed level of consciousness * 1  1/44 (2.27%) 
Dizziness * 1  5/44 (11.36%) 
Dysgeusia * 1  23/44 (52.27%) 
Dysphasia * 1  1/44 (2.27%) 
Extrapyramidal disorder * 1  1/44 (2.27%) 
Facial muscle weakness * 1  1/44 (2.27%) 
Headache * 1  10/44 (22.73%) 
Myelitis * 1  4/44 (9.09%) 
Nervous system disorders - Other * 1  1/44 (2.27%) 
Neuralgia * 1  16/44 (36.36%) 
Peripheral motor neuropathy * 1  4/44 (9.09%) 
Peripheral sensory neuropathy * 1  24/44 (54.55%) 
Tremor * 1  2/44 (4.55%) 
Psychiatric disorders   
Anxiety * 1  6/44 (13.64%) 
Confusion * 1  1/44 (2.27%) 
Depression * 1  7/44 (15.91%) 
Insomnia * 1  4/44 (9.09%) 
Psychosis * 1  1/44 (2.27%) 
Renal and urinary disorders   
Chronic kidney disease * 1  1/44 (2.27%) 
Cystitis noninfective * 1  1/44 (2.27%) 
Hematuria * 1  1/44 (2.27%) 
Urinary frequency * 1  1/44 (2.27%) 
Urinary incontinence * 1  1/44 (2.27%) 
Urine discoloration * 1  1/44 (2.27%) 
Reproductive system and breast disorders   
Irregular menstruation * 1  1/44 (2.27%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  6/44 (13.64%) 
Dyspnea * 1  1/44 (2.27%) 
Epistaxis * 1  4/44 (9.09%) 
Hiccups * 1  3/44 (6.82%) 
Laryngeal edema * 1  10/44 (22.73%) 
Laryngeal mucositis * 1  8/44 (18.18%) 
Pharyngeal hemorrhage * 1  1/44 (2.27%) 
Pharyngeal mucositis * 1  24/44 (54.55%) 
Pharyngeal stenosis * 1  1/44 (2.27%) 
Pharyngolaryngeal pain * 1  11/44 (25.00%) 
Pneumonitis * 1  1/44 (2.27%) 
Respiratory, thoracic and mediastinal disorders - Other * 1  1/44 (2.27%) 
Sinus disorder * 1  2/44 (4.55%) 
Voice alteration * 1  13/44 (29.55%) 
Skin and subcutaneous tissue disorders   
Alopecia * 1  15/44 (34.09%) 
Dry skin * 1  2/44 (4.55%) 
Palmar-plantar erythrodysesthesia syndrome * 1  1/44 (2.27%) 
Pruritus * 1  1/44 (2.27%) 
Rash maculo-papular * 1  4/44 (9.09%) 
Skin atrophy * 1  1/44 (2.27%) 
Skin hyperpigmentation * 1  12/44 (27.27%) 
Skin hypopigmentation * 1  1/44 (2.27%) 
Skin induration * 1  20/44 (45.45%) 
Vascular disorders   
Flushing * 1  1/44 (2.27%) 
Hot flashes * 1  2/44 (4.55%) 
Hypertension * 1  5/44 (11.36%) 
Lymphedema * 1  1/44 (2.27%) 
Thromboembolic event * 1  1/44 (2.27%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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.
Results Point of Contact
Name/Title: Wendy Seiferheld
Organization: Radiation Therapy Oncology Group (RTOG)
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00408694     History of Changes
Obsolete Identifiers: NCT00707096
Other Study ID Numbers: NCI-2009-00736
NCI-2009-00736 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
RTOG-0615
CDR0000518526
RTOG 0615 ( Other Identifier: Radiation Therapy Oncology Group )
RTOG-0615 ( Other Identifier: CTEP )
U10CA021661 ( U.S. NIH Grant/Contract )
First Submitted: December 6, 2006
First Posted: December 7, 2006
Results First Submitted: March 1, 2013
Results First Posted: April 18, 2013
Last Update Posted: January 30, 2018