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Trial record 11 of 24 for:    "Adenosquamous Lung Carcinoma" | "Antineoplastic Agents, Phytogenic"

Radiation Therapy Combined With Paclitaxel and Carboplatin in Treating Patients With Stage III Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00023673
Recruitment Status : Completed
First Posted : April 9, 2003
Results First Posted : March 27, 2014
Last Update Posted : December 22, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lung Cancer
Interventions Drug: carboplatin
Drug: paclitaxel
Radiation: three-dimensional conformal radiation therapy
Enrollment 63
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phase I: 75.25 Gy/36 fx + Chemotherapy Phase I: 74 Gy/37 fx + Chemotherapy Phase I: 70 Gy/35 fx + Chemotherapy Phase II: 74 Gy/37 fx + Chemotherapy
Hide Arm/Group Description Phase I: Three-dimensional conformal radiation therapy (3DRT) of 75.25 Gy given in 36 fractions (2.15 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional. Phase I: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional. Phase I: Three-dimensional conformal radiation therapy (3DRT) of 70 Gy given in 35 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional. Phase II: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
Period Title: Overall Study
Started 8 9 0 46
Completed 8 [1] 9 [1] 0 [2] 44 [3]
Not Completed 0 0 0 2
Reason Not Completed
Ineligible / no protocol treatment             0             0             0             1
Patient withdrew consent             0             0             0             1
[1]
Phase I eligible patients starting protocol treatment are considered to have completed the study.
[2]
This arm was not used since further de-escalation was not required.
[3]
Phase II subjects contributing data to primary analysis are considered to have completed the study.
Arm/Group Title Phase I: 75.25 Gy/36 fx + Chemotherapy Phase I: 74 Gy/37 fx + Chemotherapy Phase II: 74 Gy/37 fx + Chemotherapy Total
Hide Arm/Group Description Phase I: Three-dimensional conformal radiation therapy (3DRT) of 75.25 Gy given in 36 fractions (2.15 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional. Phase I: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional. Phase II: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional. Total of all reporting groups
Overall Number of Baseline Participants 8 9 44 61
Hide Baseline Analysis Population Description
Eligible patients who started protocol treatment.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 8 participants 9 participants 44 participants 61 participants
65.5
(48 to 77)
68
(52 to 81)
67
(43 to 83)
67
(43 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 9 participants 44 participants 61 participants
Female
1
  12.5%
8
  88.9%
7
  15.9%
16
  26.2%
Male
7
  87.5%
1
  11.1%
37
  84.1%
45
  73.8%
1.Primary Outcome
Title Maximum Tolerated Dose (MTD) of Three-dimensional Conformal Radiation Therapy (3DRT), in Terms of Gy Per Fraction, Combined With Concurrent Chemotherapy
Hide Description

Dose limiting toxicity (DLT) = Grade 3/4 non-hematologic toxicities (excluding nausea, vomiting, and alopecia) and Grade 4 hematologic toxicities. The DLT rate for this study was set at 40% based on Radiation Therapy Oncology Group (RTOG) study 94-10. No acute (within 90 days from start of 3DRT) DLT's in the first 5 patients (0/5) or the combination of one acute DLT in the first 5 patients (1/5) and none in the next 2 patients (0/2) was required to deem a given dose level to be acceptable. If at any time a Grade 5 toxicity (death) occurred, accrual would be suspended and the event reviewed by a study chair. At any given dose level, this design gives at least 90% confidence that the true acute DLT rate is less than 40% and the probability of not escalating when the true toxicity rate is 40% or higher is at least 83%.

Rating scale: 0 = not the MTD, 1 = MTD

Time Frame From start of treatment to 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
The first seven eligible patients who started protocol treatment at each dose level.
Arm/Group Title Phase I: 75.25 Gy/36 fx + Chemotherapy Phase I: 74 Gy/37 fx + Chemotherapy
Hide Arm/Group Description:
Phase I: Three-dimensional conformal radiation therapy (3DRT) of 75.25 Gy given in 36 fractions (2.15 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
Phase I: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
Overall Number of Participants Analyzed 7 7
Measure Type: Number
Unit of Measure: units on a scale
0 1
2.Primary Outcome
Title Percentage of Patients Who Survive at Least 12 Months
Hide Description Null hypothesis: p<= 62.3% (the best arm of RTOG 94-10); alternative hypothesis: p>= 77.9%. Where p is the percentage of patients alive at at 12 months. Using a one-group chi-square test with alpha = 0.10, a sample size of 50 patients provides at least 87% power to detect a 25% or greater relative increase in the 12-month survival rate, or equivalently, an absolute increase of at least 15.6 percentage points (62.3 versus 77.9). If the point estimate is greater than 71.1% (upper bound), then the conclusion is that the 12-month survival rate from the new treatment significantly improved from 62.3%.
Time Frame From registration to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients at the MTD dose level who started protocol treatment.
Arm/Group Title Phase I/II: 74 Gy/37 fx + Chemotherapy
Hide Arm/Group Description:

Phase I/II: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.

carboplatin

paclitaxel

three-dimensional conformal radiation therapy

Overall Number of Participants Analyzed 53
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
75.5
(61.5 to 85.0)
3.Secondary Outcome
Title Frequency of Highest Grade Chemotherapy/Acute RT Toxicities and Late RT Toxicities.
Hide Description Highest grade toxicity per subject was counted. Toxicities were graded using the Common Toxicity Criteria (CTC) v 2.0 for chemotherapy/acute RT toxicities and using the RTOG/EORTC Late Toxicity Criteria for late RT toxicity. Grade refers to the severity of the toxicity. Both criteria assign Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity.Chemotherapy/Acute RT toxicities occur during chemotherapy and/or within 90 days of the start of RT. Late RT toxicities occur more than 90 days after the start of RT.
Time Frame Chemotherapy/Acute RT toxicity: from start of treatment to 90 days from start of study treatment; Late RT toxicity: from 90 days after start of treatment to last follow-up (Maximum follow-up = 57.9 months.)
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients from Phase I and II 74 Gy arms who started study treatment. Additionally for late RT toxicity, those who have toxicity data at least 90 days from start of RT.
Arm/Group Title Phase I/II: 74 Gy/37 fx + Chemotherapy
Hide Arm/Group Description:
Phase I/II: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
Overall Number of Participants Analyzed 53
Measure Type: Count of Participants
Unit of Measure: Participants
Chemotherapy/Acute RT non-hematologic: Grade 1 Number Analyzed 53 participants
4
   7.5%
Chemotherapy/Acute RT non-hematologic: Grade 2 Number Analyzed 53 participants
16
  30.2%
Chemotherapy/Acute RT non-hematologic: Grade 3 Number Analyzed 53 participants
28
  52.8%
Chemotherapy/Acute RT non-hematologic: Grade 4 Number Analyzed 53 participants
2
   3.8%
Chemotherapy/Acute RT non-hematologic: Grade 5 Number Analyzed 53 participants
2
   3.8%
Chemotherapy/Acute RT hematologic: Grade 1 Number Analyzed 53 participants
1
   1.9%
Chemotherapy/Acute RT hematologic: Grade 2 Number Analyzed 53 participants
8
  15.1%
Chemotherapy/Acute RT hematologic: Grade 3 Number Analyzed 53 participants
37
  69.8%
Chemotherapy/Acute RT hematologic: Grade 4 Number Analyzed 53 participants
5
   9.4%
Chemotherapy/Acute RT hematologic: Grade 5 Number Analyzed 53 participants
2
   3.8%
Late RT toxicity: Grade 1 Number Analyzed 50 participants
13
  26.0%
Late RT toxicity: Grade 2 Number Analyzed 50 participants
10
  20.0%
Late RT toxicity: Grade 3 Number Analyzed 50 participants
9
  18.0%
Late RT toxicity: Grade 4 Number Analyzed 50 participants
1
   2.0%
Late RT toxicity: Grade 5 Number Analyzed 50 participants
1
   2.0%
4.Secondary Outcome
Title Partial Organ Tolerance Doses for Lung and Esophagus (Percent Volume of Total Lung Receiving > 20 Gy by Toxicity Level)
Hide Description Percent volume of total lung receiving > 20 Gy radiation therapy (Lung V20) was compared between the two patient groups of those who experienced a grade 3 and higher lung toxicity and those who did not. Similarly, it was also compared between the two patient groups of those who experienced a grade 2 and higher esophageal toxicity and those who did not. Toxicities graded using CTC v 2.0 for chemotherapy/acute RT toxicities and using the RTOG/EORTC Late Toxicity Criteria for late RT toxicity. Grade refers to the severity of the toxicity. Both criteria assign Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity.
Time Frame From start of treatment to last follow-up (Maximum follow-up = 57.9 months.)
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients on the phase I and II 74 Gy arms who received treatment and had RT plan data available with the given structure
Arm/Group Title No High Grade Toxicity High Grade Toxicity
Hide Arm/Group Description:
For lung toxicity, no high grade toxicity means < Grade 3. For esophagitis toxicity, no high grade toxicity means < Grade 2. Therefore overall number of participants analyzed differs.
For lung toxicity, high grade toxicity means >= Grade 3. For esophagitis toxicity, high grade toxicity means >= Grade 2. Therefore overall number of participants analyzed differs.
Overall Number of Participants Analyzed 53 53
Median (Full Range)
Unit of Measure: Percent (V20)
Lung Toxicity: Lung V20 Number Analyzed 39 participants 12 participants
24.1
(9.9 to 35.7)
26.3
(15.6 to 33.3)
Esophagitis Toxicity: Lung V20 Number Analyzed 30 participants 21 participants
22.4
(9.9 to 35.7)
26.3
(14.0 to 33.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No High Grade Toxicity, High Grade Toxicity
Comments Lung toxicity (<Grade 3 vs. >= Grade 3): Lung V20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.62
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 2-sided significance level = 0.05
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection No High Grade Toxicity, High Grade Toxicity
Comments Esophagitis toxicity (<Grade 2 vs. >= Grade 2): Lung V20
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 2-sided significance level = 0.05
5.Secondary Outcome
Title Partial Organ Tolerance Doses for Lung and Esophagus (Mean Organ Dose by Toxicity Level)
Hide Description Mean lung dose was compared between the two patient groups of those who experienced a grade 3 and higher lung toxicity and those who did not. Similarly, mean lung dose, and mean esophageal dose were compared between the two patient groups of those who experienced a grade 2 and higher esophageal toxicity and those who did not. Toxicities graded using CTC v 2.0 for chemotherapy/acute RT toxicities and using the RTOG/EORTC Late Toxicity Criteria for late RT toxicity. Grade refers to the severity of the toxicity. Both criteria assign Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity.
Time Frame From start of treatment to last follow-up (Maximum follow-up = 57.9 months.)
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients on the phase I and II 74 Gy arms who received treatment and had RT plan data available with the given structure
Arm/Group Title No High Grade Toxicity High Grade Toxicity
Hide Arm/Group Description:
For lung toxicity, no high grade toxicity means < Grade 3. For esophagitis toxicity, no high grade toxicity means < Grade 2. Therefore overall number of participants analyzed differs.
For lung toxicity, high grade toxicity means >= Grade 3. For esophagitis toxicity, high grade toxicity means >= Grade 2. Therefore overall number of participants analyzed differs.
Overall Number of Participants Analyzed 53 53
Mean (Full Range)
Unit of Measure: Gy (mean dose)
Lung Toxicity: Mean Lung Dose Number Analyzed 39 participants 12 participants
15.2
(5.7 to 21.8)
17.2
(11.5 to 18.9)
Esophagitis Toxicity: Mean Lung Dose Number Analyzed 30 participants 21 participants
14.5
(5.7 to 21.8)
16.9
(9.9 to 20.6)
Esophagitis Toxicity: Mean Esophageal Dose Number Analyzed 30 participants 22 participants
21.0
(7.1 to 34.9)
24.6
(16.2 to 33.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No High Grade Toxicity, High Grade Toxicity
Comments Lung toxicity (<Grade 3 vs. >= Grade 3): Mean Lung Dose
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.30
Comments [Not Specified]
Method t-test, 2 sided
Comments 2-sided significance level = 0.05
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection No High Grade Toxicity, High Grade Toxicity
Comments Esophagitis toxicity (<Grade 2 vs. >= Grade 2): Mean Lung Dose
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method t-test, 2 sided
Comments 2-sided significance level = 0.05
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection No High Grade Toxicity, High Grade Toxicity
Comments Esophagitis toxicity (<Grade 2 vs. >= Grade 2): Mean Esophageal Dose
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method t-test, 2 sided
Comments 2-sided significance level = 0.05
6.Secondary Outcome
Title Number of Patients With Complete Response at 3 Months After Completion of Therapy
Hide Description "Complete response" means no evidence of tumor on the CT scan.
Time Frame From start of treatment until 3 months after completion of all study treatment, estimated to be 5 or 6.5 months depending whether or not subject received optional adjuvant chemotherapy.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients from Phase I and II 74 Gy arms who started study treatment.
Arm/Group Title Phase I/II: 74 Gy/37 fx + Chemotherapy
Hide Arm/Group Description:
Phase I/II: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
Overall Number of Participants Analyzed 53
Measure Type: Count of Participants
Unit of Measure: Participants
3
   5.7%
Time Frame [Not Specified]
Adverse Event Reporting Description Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
 
Arm/Group Title Phase I: 75.25 Gy/36 fx + Chemotherapy Phase I/II: 74 Gy/37 fx + Chemotherapy
Hide Arm/Group Description Phase I: Three-dimensional conformal radiation therapy (3DRT) of 75.25 Gy given in 36 fractions (2.15 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional. Phase I: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
All-Cause Mortality
Phase I: 75.25 Gy/36 fx + Chemotherapy Phase I/II: 74 Gy/37 fx + Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Phase I: 75.25 Gy/36 fx + Chemotherapy Phase I/II: 74 Gy/37 fx + Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   7/8 (87.50%)   36/53 (67.92%) 
Blood and lymphatic system disorders     
Hemoglobin decreased * 1  2/8 (25.00%)  1/53 (1.89%) 
Hemolysis NOS * 1  0/8 (0.00%)  1/53 (1.89%) 
Packed red blood cell transfusion * 1  0/8 (0.00%)  1/53 (1.89%) 
Platelet transfusion * 1  0/8 (0.00%)  1/53 (1.89%) 
Cardiac disorders     
Arrhythmia NOS * 1  0/8 (0.00%)  2/53 (3.77%) 
Sinus tachycardia * 1  1/8 (12.50%)  0/53 (0.00%) 
Supraventricular arrhythmia NOS * 1  0/8 (0.00%)  2/53 (3.77%) 
Gastrointestinal disorders     
Dyspepsia * 1  0/8 (0.00%)  1/53 (1.89%) 
Dysphagia * 1  0/8 (0.00%)  1/53 (1.89%) 
Esophageal spasm * 1  0/8 (0.00%)  3/53 (5.66%) 
Esophagitis NOS * 1  0/8 (0.00%)  2/53 (3.77%) 
GI-other * 1  0/8 (0.00%)  2/53 (3.77%) 
Ileus * 1  0/8 (0.00%)  1/53 (1.89%) 
Nausea * 1  0/8 (0.00%)  2/53 (3.77%) 
Vomiting NOS * 1  0/8 (0.00%)  2/53 (3.77%) 
General disorders     
Late RT Toxicity: Esophagus  2  0/8 (0.00%)  4/53 (7.55%) 
Late RT Toxicity: Heart  2  0/8 (0.00%)  1/53 (1.89%) 
Late RT Toxicity: Lung  2  1/8 (12.50%)  8/53 (15.09%) 
Late RT Toxicity: Other  2  1/8 (12.50%)  0/53 (0.00%) 
Pain-other * 1  1/8 (12.50%)  0/53 (0.00%) 
Immune system disorders     
Hypersensitivity NOS * 1  1/8 (12.50%)  2/53 (3.77%) 
Infections and infestations     
Infection NOS * 1  1/8 (12.50%)  5/53 (9.43%) 
Infection with grade 3 or 4 neutropenia * 1  0/8 (0.00%)  1/53 (1.89%) 
Infection with unknown ANC * 1  0/8 (0.00%)  1/53 (1.89%) 
Infection, Other * 1  0/8 (0.00%)  1/53 (1.89%) 
Injury, poisoning and procedural complications     
Dermatitis radiation NOS * 1  0/8 (0.00%)  1/53 (1.89%) 
Operative injury of vein/artery * 1  0/8 (0.00%)  1/53 (1.89%) 
Investigations     
Cardiac troponin I increased * 1  1/8 (12.50%)  0/53 (0.00%) 
Leukopenia NOS * 1  1/8 (12.50%)  19/53 (35.85%) 
Lymphopenia * 1  0/8 (0.00%)  1/53 (1.89%) 
Neutropenia * 1  0/8 (0.00%)  1/53 (1.89%) 
Metabolism and nutrition disorders     
Anorexia * 1  0/8 (0.00%)  2/53 (3.77%) 
Dehydration * 1  1/8 (12.50%)  3/53 (5.66%) 
Hyperglycemia NOS * 1  1/8 (12.50%)  4/53 (7.55%) 
Hypokalemia * 1  0/8 (0.00%)  1/53 (1.89%) 
Musculoskeletal and connective tissue disorders     
Muscle weakness NOS * 1  1/8 (12.50%)  0/53 (0.00%) 
Nervous system disorders     
Convulsions NOS * 1  1/8 (12.50%)  0/53 (0.00%) 
Syncope * 1  0/8 (0.00%)  2/53 (3.77%) 
Renal and urinary disorders     
Renal failure NOS * 1  0/8 (0.00%)  1/53 (1.89%) 
Renal/GU-Other * 1  0/8 (0.00%)  1/53 (1.89%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea NOS * 1  1/8 (12.50%)  7/53 (13.21%) 
Hemoptysis * 1  0/8 (0.00%)  1/53 (1.89%) 
Hypoxia * 1  0/8 (0.00%)  3/53 (5.66%) 
Pleural effusion * 1  1/8 (12.50%)  0/53 (0.00%) 
Pneumonitis NOS * 1  2/8 (25.00%)  2/53 (3.77%) 
Pulmonary-other * 1  0/8 (0.00%)  2/53 (3.77%) 
Vascular disorders     
Hypotension NOS * 1  0/8 (0.00%)  2/53 (3.77%) 
Peripheral ischaemia NOS * 1  0/8 (0.00%)  1/53 (1.89%) 
Thrombosis NOS * 1  0/8 (0.00%)  3/53 (5.66%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (2.0)
2
Term from vocabulary, RTOG/EORTC Late Tox.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Phase I: 75.25 Gy/36 fx + Chemotherapy Phase I/II: 74 Gy/37 fx + Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   8/8 (100.00%)   52/53 (98.11%) 
Blood and lymphatic system disorders     
Hematologic-Other * 1  0/8 (0.00%)  6/53 (11.32%) 
Hemoglobin decreased * 1  5/8 (62.50%)  34/53 (64.15%) 
Cardiac disorders     
Pericardial effusion * 1  0/8 (0.00%)  2/53 (3.77%) 
Sinus tachycardia * 1  0/8 (0.00%)  3/53 (5.66%) 
Supraventricular arrhythmia NOS * 1  0/8 (0.00%)  3/53 (5.66%) 
Ear and labyrinth disorders     
Hearing-Other * 1  0/8 (0.00%)  3/53 (5.66%) 
Gastrointestinal disorders     
Abdominal pain NOS * 1  0/8 (0.00%)  2/53 (3.77%) 
Constipation * 1  0/8 (0.00%)  22/53 (41.51%) 
Diarrhea NOS * 1  1/8 (12.50%)  9/53 (16.98%) 
Dry mouth * 1  1/8 (12.50%)  0/53 (0.00%) 
Dyspepsia * 1  0/8 (0.00%)  9/53 (16.98%) 
Dysphagia * 1  1/8 (12.50%)  3/53 (5.66%) 
Esophageal spasm * 1  3/8 (37.50%)  17/53 (32.08%) 
Esophagitis NOS * 1  2/8 (25.00%)  19/53 (35.85%) 
GI-other * 1  1/8 (12.50%)  2/53 (3.77%) 
Gastritis NOS * 1  0/8 (0.00%)  2/53 (3.77%) 
Nausea * 1  2/8 (25.00%)  17/53 (32.08%) 
Radiation mucositis * 1  0/8 (0.00%)  4/53 (7.55%) 
Rectal bleeding * 1  1/8 (12.50%)  0/53 (0.00%) 
Stomatitis * 1  0/8 (0.00%)  4/53 (7.55%) 
Vomiting NOS * 1  1/8 (12.50%)  9/53 (16.98%) 
General disorders     
Chest pain * 1  0/8 (0.00%)  3/53 (5.66%) 
Edema NOS * 1  1/8 (12.50%)  2/53 (3.77%) 
Fatigue * 1  2/8 (25.00%)  40/53 (75.47%) 
Late RT Toxicity: Bone  2  1/8 (12.50%)  1/53 (1.89%) 
Late RT Toxicity: Esophagus  2  4/8 (50.00%)  9/53 (16.98%) 
Late RT Toxicity: Heart  2  1/8 (12.50%)  4/53 (7.55%) 
Late RT Toxicity: Lung  2  5/8 (62.50%)  26/53 (49.06%) 
Late RT Toxicity: Other  2  2/8 (25.00%)  8/53 (15.09%) 
Late RT Toxicity: Skin (within the irradiated field)  2  1/8 (12.50%)  5/53 (9.43%) 
Late RT Toxicity: Spinal cord  2  1/8 (12.50%)  1/53 (1.89%) 
Late RT Toxicity: Subcutaneous tissue  2  1/8 (12.50%)  2/53 (3.77%) 
Pain due to radiation * 1  0/8 (0.00%)  11/53 (20.75%) 
Pain-other * 1  1/8 (12.50%)  13/53 (24.53%) 
Pyrexia * 1  0/8 (0.00%)  9/53 (16.98%) 
Rigors * 1  0/8 (0.00%)  1/53 (1.89%) 
Hepatobiliary disorders     
Hepatic-Other * 1  0/8 (0.00%)  4/53 (7.55%) 
Immune system disorders     
Hypersensitivity NOS * 1  0/8 (0.00%)  1/53 (1.89%) 
Infections and infestations     
Infection NOS * 1  2/8 (25.00%)  2/53 (3.77%) 
Infection with unknown ANC * 1  0/8 (0.00%)  1/53 (1.89%) 
Injury, poisoning and procedural complications     
Dermatitis radiation NOS * 1  2/8 (25.00%)  14/53 (26.42%) 
Investigations     
Activated partial thromboplastin time prolonged * 1  0/8 (0.00%)  2/53 (3.77%) 
Alanine aminotransferase increased * 1  1/8 (12.50%)  6/53 (11.32%) 
Aspartate aminotransferase increased * 1  0/8 (0.00%)  1/53 (1.89%) 
Blood alkaline phosphatase NOS increased * 1  2/8 (25.00%)  3/53 (5.66%) 
Blood bilirubin increased * 1  0/8 (0.00%)  2/53 (3.77%) 
Blood creatine phosphokinase increased * 1  0/8 (0.00%)  1/53 (1.89%) 
Blood creatinine increased * 1  0/8 (0.00%)  5/53 (9.43%) 
Forced expiratory volume decreased * 1  0/8 (0.00%)  1/53 (1.89%) 
Leukopenia NOS * 1  6/8 (75.00%)  29/53 (54.72%) 
Lymphopenia * 1  2/8 (25.00%)  17/53 (32.08%) 
Metabolic-Other * 1  0/8 (0.00%)  2/53 (3.77%) 
Neutropenia * 1  2/8 (25.00%)  25/53 (47.17%) 
Platelet count decreased * 1  2/8 (25.00%)  20/53 (37.74%) 
Prothrombin time prolonged * 1  1/8 (12.50%)  3/53 (5.66%) 
Weight decreased * 1  2/8 (25.00%)  13/53 (24.53%) 
Metabolism and nutrition disorders     
Anorexia * 1  2/8 (25.00%)  21/53 (39.62%) 
Blood albumin decreased * 1  1/8 (12.50%)  8/53 (15.09%) 
Blood bicarbonate decreased * 1  0/8 (0.00%)  1/53 (1.89%) 
Blood magnesium decreased * 1  1/8 (12.50%)  3/53 (5.66%) 
Dehydration * 1  0/8 (0.00%)  5/53 (9.43%) 
Hypercalcemia * 1  0/8 (0.00%)  1/53 (1.89%) 
Hyperglycemia NOS * 1  3/8 (37.50%)  6/53 (11.32%) 
Hyperkalemia * 1  0/8 (0.00%)  2/53 (3.77%) 
Hypernatremia * 1  0/8 (0.00%)  1/53 (1.89%) 
Hypocalcemia * 1  2/8 (25.00%)  4/53 (7.55%) 
Hypoglycaemia NOS * 1  0/8 (0.00%)  1/53 (1.89%) 
Hypokalemia * 1  0/8 (0.00%)  1/53 (1.89%) 
Hyponatremia * 1  2/8 (25.00%)  3/53 (5.66%) 
Hypophosphatemia * 1  0/8 (0.00%)  1/53 (1.89%) 
Musculoskeletal and connective tissue disorders     
Bone pain * 1  0/8 (0.00%)  2/53 (3.77%) 
Joint, muscle, or bone-Other * 1  1/8 (12.50%)  2/53 (3.77%) 
Myalgia * 1  1/8 (12.50%)  4/53 (7.55%) 
Nervous system disorders     
Amnesia NEC * 1  0/8 (0.00%)  1/53 (1.89%) 
Ataxia NEC * 1  0/8 (0.00%)  1/53 (1.89%) 
Convulsions NOS * 1  2/8 (25.00%)  0/53 (0.00%) 
Dizziness (exc vertigo) * 1  1/8 (12.50%)  5/53 (9.43%) 
Headache NOS * 1  1/8 (12.50%)  4/53 (7.55%) 
Neuralgia NOS * 1  0/8 (0.00%)  2/53 (3.77%) 
Neurologic-Other * 1  0/8 (0.00%)  3/53 (5.66%) 
Peripheral motor neuropathy * 1  0/8 (0.00%)  1/53 (1.89%) 
Peripheral sensory neuropathy * 1  0/8 (0.00%)  8/53 (15.09%) 
Speech disorder NEC * 1  0/8 (0.00%)  1/53 (1.89%) 
Taste disturbance * 1  0/8 (0.00%)  5/53 (9.43%) 
Tremor NEC * 1  0/8 (0.00%)  1/53 (1.89%) 
Psychiatric disorders     
Anxiety NEC * 1  0/8 (0.00%)  5/53 (9.43%) 
Confusion * 1  0/8 (0.00%)  2/53 (3.77%) 
Depression NEC * 1  0/8 (0.00%)  5/53 (9.43%) 
Insomnia NEC * 1  0/8 (0.00%)  12/53 (22.64%) 
Libido decreased * 1  0/8 (0.00%)  1/53 (1.89%) 
Renal and urinary disorders     
Renal failure NOS * 1  0/8 (0.00%)  1/53 (1.89%) 
Renal/GU-Other * 1  0/8 (0.00%)  2/53 (3.77%) 
Ureteric obstruction * 1  0/8 (0.00%)  1/53 (1.89%) 
Urinary frequency * 1  0/8 (0.00%)  1/53 (1.89%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  0/8 (0.00%)  24/53 (45.28%) 
Dysphonia * 1  0/8 (0.00%)  4/53 (7.55%) 
Dyspnea NOS * 1  2/8 (25.00%)  18/53 (33.96%) 
Epistaxis * 1  0/8 (0.00%)  1/53 (1.89%) 
Hemoptysis * 1  0/8 (0.00%)  4/53 (7.55%) 
Hiccups * 1  1/8 (12.50%)  1/53 (1.89%) 
Pleural effusion * 1  0/8 (0.00%)  1/53 (1.89%) 
Pleuritic pain * 1  1/8 (12.50%)  0/53 (0.00%) 
Pneumonitis NOS * 1  0/8 (0.00%)  2/53 (3.77%) 
Pneumothorax NOS * 1  0/8 (0.00%)  2/53 (3.77%) 
Pulmonary-other * 1  0/8 (0.00%)  1/53 (1.89%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  0/8 (0.00%)  10/53 (18.87%) 
Dermatitis exfoliative NOS * 1  2/8 (25.00%)  3/53 (5.66%) 
Dry skin * 1  0/8 (0.00%)  2/53 (3.77%) 
Erythema multiforme * 1  0/8 (0.00%)  1/53 (1.89%) 
Nail abnormality NOS * 1  0/8 (0.00%)  3/53 (5.66%) 
Skin discoloration * 1  0/8 (0.00%)  1/53 (1.89%) 
Skin-Other * 1  1/8 (12.50%)  1/53 (1.89%) 
Vascular disorders     
Flushing * 1  0/8 (0.00%)  1/53 (1.89%) 
Hypertension NOS * 1  0/8 (0.00%)  1/53 (1.89%) 
Hypotension NOS * 1  0/8 (0.00%)  3/53 (5.66%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (2.0)
2
Term from vocabulary, RTOG/EORTC Late Tox.
This study was originally designed to escalate 3DRT via increasing doses per fraction. However, due to excessive toxicity at dose level 1 (75.25 Gy, 2.15 Gy/fraction), the protocol was amended in January 2003 to de-escalate 3DRT dose.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00023673     History of Changes
Other Study ID Numbers: RTOG L-0117
CDR0000068850 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2012-02401 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
First Submitted: September 13, 2001
First Posted: April 9, 2003
Results First Submitted: February 12, 2014
Results First Posted: March 27, 2014
Last Update Posted: December 22, 2017