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Erlotinib Hydrochloride or Crizotinib and Chemoradiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01822496
Recruitment Status : Terminated
First Posted : April 2, 2013
Results First Posted : August 5, 2019
Last Update Posted : August 5, 2019
Sponsor:
Collaborator:
NRG Oncology
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Stage III Non-Small Cell Lung Cancer AJCC v7
Stage IIIA Non-Small Cell Lung Cancer AJCC v7
Stage IIIB Non-Small Cell Lung Cancer AJCC v7
Interventions Radiation: Radiation Therapy
Drug: Carboplatin
Drug: Cisplatin
Drug: Crizotinib
Drug: Erlotinib
Drug: Etoposide
Drug: Paclitaxel
Enrollment 59
Recruitment Details  
Pre-assignment Details  
Arm/Group Title EGFR: Erlotinib EGFR: No Erlotinib ALK: Crizotinib ALK: No Crizotinib
Hide Arm/Group Description Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately. Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately. Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
Period Title: Overall Study
Started 16 23 9 11
Eligible 14 21 9 7
Eligible With Disease Assessment 10 15 6 4
Eligible and Started Study Treatment 14 20 9 7
Completed [1] 14 21 9 7
Not Completed 2 2 0 4
Reason Not Completed
Protocol Violation             2             2             0             1
Withdrawal by Subject             0             0             0             3
[1]
Subjects contributing any data to results are considered to have completed the study
Arm/Group Title EGFR: Erlotinib EGFR: No Erlotinib ALK: Crizotinib ALK: No Crizotinib Total
Hide Arm/Group Description Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately. Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately. Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Total of all reporting groups
Overall Number of Baseline Participants 14 21 9 7 51
Hide Baseline Analysis Population Description
Eligible patients
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age (years) Number Analyzed 14 participants 21 participants 9 participants 7 participants 51 participants
≤ 49
2
  14.3%
3
  14.3%
3
  33.3%
0
   0.0%
8
  15.7%
50 - 59
4
  28.6%
5
  23.8%
4
  44.4%
2
  28.6%
15
  29.4%
60 -69
4
  28.6%
9
  42.9%
2
  22.2%
1
  14.3%
16
  31.4%
≥ 70
4
  28.6%
4
  19.0%
0
   0.0%
4
  57.1%
12
  23.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 21 participants 9 participants 7 participants 51 participants
Female
4
  28.6%
6
  28.6%
4
  44.4%
5
  71.4%
19
  37.3%
Male
10
  71.4%
15
  71.4%
5
  55.6%
2
  28.6%
32
  62.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 21 participants 9 participants 7 participants 51 participants
Hispanic or Latino
1
   7.1%
2
   9.5%
0
   0.0%
0
   0.0%
3
   5.9%
Not Hispanic or Latino
13
  92.9%
19
  90.5%
9
 100.0%
6
  85.7%
47
  92.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
1
   2.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 21 participants 9 participants 7 participants 51 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
  14.3%
3
  14.3%
1
  11.1%
1
  14.3%
7
  13.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   4.8%
1
  11.1%
0
   0.0%
2
   3.9%
White
12
  85.7%
15
  71.4%
7
  77.8%
5
  71.4%
39
  76.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
1
   2.0%
Unknown or Not Reported
0
   0.0%
2
   9.5%
0
   0.0%
0
   0.0%
2
   3.9%
1.Primary Outcome
Title Progression-free Survival
Hide Description Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST) guideline v1.1 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions at any location. Progression-free survival time is measured from the date of randomization to the date of first progression, death, or last known follow-up (censored). No statistical testing was done due to early study termination.
Time Frame From randomization to study termination. Maximum follow-up was 39.0 months
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients
Arm/Group Title EGFR: Erlotinib EGFR: No Erlotinib ALK: Crizotinib ALK: No Crizotinib
Hide Arm/Group Description:
Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
Overall Number of Participants Analyzed 14 21 9 7
Median (95% Confidence Interval)
Unit of Measure: months
21.1 [1] 
(8.5 to NA)
9.2 [1] 
(8.7 to NA)
14.7
(6.4 to 19.5)
NA [1] 
(NA to NA)
[1]
Not reached
2.Secondary Outcome
Title Percentage of Patients With Complete or Partial Response
Hide Description Per the RECIST guideline v1.1 complete response is defined as the disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. No statistical testing was done due to early study termination.
Time Frame From randomization to study termination. Maximum follow-up was 39.0 months
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with disease assessment
Arm/Group Title EGFR: Erlotinib EGFR: No Erlotinib ALK: Crizotinib ALK: No Crizotinib
Hide Arm/Group Description:
Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
Overall Number of Participants Analyzed 10 15 6 4
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
50.0
(19.0 to 81.0)
26.7
(4.3 to 49.1)
66.7
(29.0 to 100.0)
75.0
(32.6 to 100.0)
3.Secondary Outcome
Title Number of Patients With Grade 3-5 Adverse Events
Hide Description Adverse events (AE) are graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 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 randomization to study termination. Maximum follow-up was 39.0 months
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title EGFR: Erlotinib EGFR: No Erlotinib ALK: Crizotinib ALK: No Crizotinib
Hide Arm/Group Description:
Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
Overall Number of Participants Analyzed 14 20 9 7
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Overall Survival
Hide Description Overall survival time is defined as time from randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
Time Frame From randomization to study termination. Maximum follow-up was 39.0 months
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients
Arm/Group Title EGFR: Erlotinib EGFR: No Erlotinib ALK: Crizotinib ALK: No Crizotinib
Hide Arm/Group Description:
Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
Overall Number of Participants Analyzed 14 21 9 7
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
35.9 [1] 
(35.9 to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Not reached
5.Secondary Outcome
Title Local-regional Progression-free Survival
Hide Description Progression is defined using the RECIST guideline v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new regional lesions. Local progression is defined as progression within the planning target volume (PTV). Regional progression is defined as progression outside of the PTV but within the same lobe of the lung as the primary tumor or in regional lymph nodes as defined by the American Joint Committee on Cancer (AJCC) 7th edition nodal stations. Local-regional progression-free survival time is measured from the date of randomization to the date of first local-regional progression, death, or last known follow-up (censored). Local-regional progression-free survival rates are estimated using the Kaplan-Meier method. No testing was done due to early study termination.
Time Frame From randomization to study termination. Maximum follow-up was 39.0 months
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients
Arm/Group Title EGFR: Erlotinib EGFR: No Erlotinib ALK: Crizotinib ALK: No Crizotinib
Hide Arm/Group Description:
Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
Overall Number of Participants Analyzed 14 21 9 7
Median (95% Confidence Interval)
Unit of Measure: Months
25.7 [1] 
(8.5 to NA)
NA [1] 
(NA to NA)
14.7
(6.4 to 19.5)
NA [1] 
(NA to NA)
[1]
Not reached
6.Secondary Outcome
Title Distant Progression-free Survival
Hide Description Distant progression is defined as the first occurrence of distant metastasis. Distant progression-free survival time is measured from the date of randomization to the date of first distant progression, death, or last known follow-up (censored). Distant progression-free survival rates are estimated using the Kaplan-Meier method. No testing was done due to early study termination.
Time Frame From randomization to study termination. Maximum follow-up was 39.0 months
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients
Arm/Group Title EGFR: Erlotinib EGFR: No Erlotinib ALK: Crizotinib ALK: No Crizotinib
Hide Arm/Group Description:
Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
Overall Number of Participants Analyzed 14 21 9 7
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
35.9
(8.9 to 35.9)
NA [1] 
(NA to NA)
20.1 [1] 
(7.8 to NA)
[1]
Not reached
7.Secondary Outcome
Title Correlation Between Clinical Outcomes and Tumor Molecular Aberrations
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
The data required for this analysis was not obtained and will not be obtained.
Arm/Group Title EGFR: Erlotinib EGFR: No Erlotinib ALK: Crizotinib ALK: No Crizotinib
Hide Arm/Group Description:
Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame From randomization to last follow-up. Maximum follow-up was 39.0 months.
Adverse Event Reporting Description Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
 
Arm/Group Title EGFR: Erlotinib EGFR: No Erlotinib ALK: Crizotinib ALK: No Crizotinib
Hide Arm/Group Description Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately. Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately. Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
All-Cause Mortality
EGFR: Erlotinib EGFR: No Erlotinib ALK: Crizotinib ALK: No Crizotinib
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/14 (7.14%)   3/20 (15.00%)   2/9 (22.22%)   1/7 (14.29%) 
Show Serious Adverse Events Hide Serious Adverse Events
EGFR: Erlotinib EGFR: No Erlotinib ALK: Crizotinib ALK: No Crizotinib
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/14 (7.14%)   7/20 (35.00%)   4/9 (44.44%)   2/7 (28.57%) 
Cardiac disorders         
Atrial fibrillation * 1  0/14 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Gastrointestinal disorders         
Diarrhea * 1  0/14 (0.00%)  0/20 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Esophageal fistula * 1  1/14 (7.14%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Esophageal stenosis * 1  0/14 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Esophagitis * 1  0/14 (0.00%)  0/20 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Vomiting * 1  0/14 (0.00%)  2/20 (10.00%)  1/9 (11.11%)  0/7 (0.00%) 
General disorders         
Fatigue * 1  0/14 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  1/7 (14.29%) 
Fever * 1  0/14 (0.00%)  1/20 (5.00%)  1/9 (11.11%)  0/7 (0.00%) 
General disorders and administration site conditions - Other * 1  0/14 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Infections and infestations         
Lung infection * 1  0/14 (0.00%)  2/20 (10.00%)  0/9 (0.00%)  1/7 (14.29%) 
Investigations         
Alanine aminotransferase increased * 1  0/14 (0.00%)  0/20 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Alkaline phosphatase increased * 1  0/14 (0.00%)  0/20 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Aspartate aminotransferase increased * 1  0/14 (0.00%)  0/20 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Weight loss * 1  0/14 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Metabolism and nutrition disorders         
Dehydration * 1  0/14 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Hypoalbuminemia * 1  0/14 (0.00%)  0/20 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Hyponatremia * 1  0/14 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Musculoskeletal and connective tissue disorders         
Generalized muscle weakness * 1  0/14 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Nervous system disorders         
Dizziness * 1  0/14 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Dysgeusia * 1  0/14 (0.00%)  0/20 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Psychiatric disorders         
Delirium * 1  0/14 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Aspiration * 1  0/14 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Cough * 1  0/14 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Dyspnea * 1  0/14 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Pleural effusion * 1  0/14 (0.00%)  0/20 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Pneumonitis * 1  0/14 (0.00%)  1/20 (5.00%)  1/9 (11.11%)  0/7 (0.00%) 
Skin and subcutaneous tissue disorders         
Erythema multiforme * 1  0/14 (0.00%)  0/20 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Vascular disorders         
Thromboembolic event * 1  0/14 (0.00%)  0/20 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
EGFR: Erlotinib EGFR: No Erlotinib ALK: Crizotinib ALK: No Crizotinib
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/14 (100.00%)   20/20 (100.00%)   8/9 (88.89%)   7/7 (100.00%) 
Blood and lymphatic system disorders         
Anemia * 1  8/14 (57.14%)  10/20 (50.00%)  4/9 (44.44%)  6/7 (85.71%) 
Blood and lymphatic system disorders - Other * 1  1/14 (7.14%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Cardiac disorders         
Chest pain - cardiac * 1  0/14 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Palpitations * 1  1/14 (7.14%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Sinus bradycardia * 1  0/14 (0.00%)  0/20 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Sinus tachycardia * 1  1/14 (7.14%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Ear and labyrinth disorders         
Hearing impaired * 1  0/14 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Tinnitus * 1  2/14 (14.29%)  1/20 (5.00%)  1/9 (11.11%)  0/7 (0.00%) 
Vertigo * 1  2/14 (14.29%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Endocrine disorders         
Endocrine disorders - Other * 1  0/14 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Hypothyroidism * 1  0/14 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Eye disorders         
Blurred vision * 1  2/14 (14.29%)  2/20 (10.00%)  2/9 (22.22%)  1/7 (14.29%) 
Cataract * 1  1/14 (7.14%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Dry eye * 1  2/14 (14.29%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Eye disorders - Other * 1  2/14 (14.29%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Flashing lights * 1  0/14 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Floaters * 1  1/14 (7.14%)  1/20 (5.00%)  1/9 (11.11%)  0/7 (0.00%) 
Gastrointestinal disorders         
Abdominal distension * 1  0/14 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  2/7 (28.57%) 
Abdominal pain * 1  2/14 (14.29%)  8/20 (40.00%)  1/9 (11.11%)  0/7 (0.00%) 
Anal hemorrhage * 1  0/14 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Bloating * 1  1/14 (7.14%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Colitis * 1  0/14 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Constipation * 1  6/14 (42.86%)  11/20 (55.00%)  2/9 (22.22%)  5/7 (71.43%) 
Diarrhea * 1  8/14 (57.14%)  10/20 (50.00%)  5/9 (55.56%)  2/7 (28.57%) 
Dry mouth * 1  2/14 (14.29%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Dyspepsia * 1  5/14 (35.71%)  5/20 (25.00%)  3/9 (33.33%)  1/7 (14.29%) 
Dysphagia * 1  8/14 (57.14%)  6/20 (30.00%)  1/9 (11.11%)  4/7 (57.14%) 
Esophageal obstruction * 1  1/14 (7.14%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Esophageal pain * 1  2/14 (14.29%)  2/20 (10.00%)  0/9 (0.00%)  1/7 (14.29%) 
Esophageal stenosis * 1  1/14 (7.14%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Esophagitis * 1  10/14 (71.43%)  12/20 (60.00%)  4/9 (44.44%)  3/7 (42.86%) 
Flatulence * 1  0/14 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Gastritis * 1  1/14 (7.14%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Gastroesophageal reflux disease * 1  2/14 (14.29%)  3/20 (15.00%)  0/9 (0.00%)  2/7 (28.57%) 
Gastrointestinal disorders - Other * 1  1/14 (7.14%)  2/20 (10.00%)  0/9 (0.00%)  0/7 (0.00%) 
Gastroparesis * 1  1/14 (7.14%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Hemorrhoids * 1  1/14 (7.14%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Mucositis oral * 1  3/14 (21.43%)  2/20 (10.00%)  0/9 (0.00%)  0/7 (0.00%) 
Nausea * 1  10/14 (71.43%)  16/20 (80.00%)  6/9 (66.67%)  4/7 (57.14%) 
Oral pain * 1  1/14 (7.14%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Stomach pain * 1  0/14 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Vomiting * 1  3/14 (21.43%)  6/20 (30.00%)  3/9 (33.33%)  2/7 (28.57%) 
General disorders         
Chills * 1  1/14 (7.14%)  2/20 (10.00%)  0/9 (0.00%)  0/7 (0.00%) 
Death NOS * 1  0/14 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Edema face * 1  0/14 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Edema limbs * 1  1/14 (7.14%)  2/20 (10.00%)  1/9 (11.11%)  4/7 (57.14%) 
Fatigue * 1  13/14 (92.86%)  14/20 (70.00%)  6/9 (66.67%)  7/7 (100.00%) 
Fever * 1  5/14 (35.71%)  1/20 (5.00%)  1/9 (11.11%)  0/7 (0.00%) 
Flu like symptoms * 1  0/14 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
General disorders and administration site conditions - Other * 1  1/14 (7.14%)  2/20 (10.00%)  0/9 (0.00%)  1/7 (14.29%) 
Irritability * 1  1/14 (7.14%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Malaise * 1  0/14 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Non-cardiac chest pain * 1  4/14 (28.57%)  3/20 (15.00%)  0/9 (0.00%)  2/7 (28.57%) 
Pain * 1  3/14 (21.43%)  1/20 (5.00%)  0/9 (0.00%)  3/7 (42.86%) 
Immune system disorders         
Allergic reaction * 1  1/14 (7.14%)  0/20 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Infections and infestations         
Bronchial infection * 1  0/14 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Infections and infestations - Other * 1  0/14 (0.00%)  0/20 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Lung infection * 1  1/14 (7.14%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Mucosal infection * 1  2/14 (14.29%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Otitis media * 1  1/14 (7.14%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Papulopustular rash * 1  2/14 (14.29%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Paronychia * 1  1/14 (7.14%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Rash pustular * 1  1/14 (7.14%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Sinusitis * 1  2/14 (14.29%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Skin infection * 1  1/14 (7.14%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Upper respiratory infection * 1  1/14 (7.14%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Urinary tract infection * 1  0/14 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Uterine infection * 1  1/14 (7.14%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Injury, poisoning and procedural complications         
Burn * 1  0/14 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Dermatitis radiation * 1  8/14 (57.14%)  6/20 (30.00%)  1/9 (11.11%)  4/7 (57.14%) 
Investigations         
Activated partial thromboplastin time prolonged * 1  0/14 (0.00%)  0/20 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Alanine aminotransferase increased * 1  4/14 (28.57%)  2/20 (10.00%)  2/9 (22.22%)  1/7 (14.29%) 
Alkaline phosphatase increased * 1  2/14 (14.29%)  1/20 (5.00%)  1/9 (11.11%)  2/7 (28.57%) 
Aspartate aminotransferase increased * 1  2/14 (14.29%)  3/20 (15.00%)  2/9 (22.22%)  1/7 (14.29%) 
Blood bilirubin increased * 1  3/14 (21.43%)  1/20 (5.00%)  0/9 (0.00%)  1/7 (14.29%) 
Creatinine increased * 1  2/14 (14.29%)  5/20 (25.00%)  0/9 (0.00%)  0/7 (0.00%) 
INR increased * 1  0/14 (0.00%)  0/20 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Investigations - Other * 1  1/14 (7.14%)  0/20 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Lymphocyte count decreased * 1  8/14 (57.14%)  10/20 (50.00%)  2/9 (22.22%)  4/7 (57.14%) 
Neutrophil count decreased * 1  4/14 (28.57%)  7/20 (35.00%)  3/9 (33.33%)  3/7 (42.86%) 
Platelet count decreased * 1  5/14 (35.71%)  9/20 (45.00%)  2/9 (22.22%)  5/7 (71.43%) 
Weight gain * 1  1/14 (7.14%)  1/20 (5.00%)  0/9 (0.00%)  1/7 (14.29%) 
Weight loss * 1  5/14 (35.71%)  3/20 (15.00%)  0/9 (0.00%)  1/7 (14.29%) 
White blood cell decreased * 1  5/14 (35.71%)  6/20 (30.00%)  4/9 (44.44%)  4/7 (57.14%) 
Metabolism and nutrition disorders         
Anorexia * 1  6/14 (42.86%)  9/20 (45.00%)  2/9 (22.22%)  3/7 (42.86%) 
Dehydration * 1  4/14 (28.57%)  4/20 (20.00%)  1/9 (11.11%)  0/7 (0.00%) 
Hypercalcemia * 1  0/14 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Hyperglycemia * 1  3/14 (21.43%)  6/20 (30.00%)  2/9 (22.22%)  5/7 (71.43%) 
Hyperkalemia * 1  0/14 (0.00%)  1/20 (5.00%)  1/9 (11.11%)  2/7 (28.57%) 
Hypoalbuminemia * 1  3/14 (21.43%)  4/20 (20.00%)  3/9 (33.33%)  3/7 (42.86%) 
Hypocalcemia * 1  0/14 (0.00%)  0/20 (0.00%)  1/9 (11.11%)  2/7 (28.57%) 
Hypoglycemia * 1  0/14 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Hypokalemia * 1  4/14 (28.57%)  3/20 (15.00%)  0/9 (0.00%)  0/7 (0.00%) 
Hypomagnesemia * 1  3/14 (21.43%)  3/20 (15.00%)  0/9 (0.00%)  0/7 (0.00%) 
Hyponatremia * 1  3/14 (21.43%)  2/20 (10.00%)  1/9 (11.11%)  2/7 (28.57%) 
Metabolism and nutrition disorders - Other * 1  0/14 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  1/14 (7.14%)  0/20 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Back pain * 1  2/14 (14.29%)  6/20 (30.00%)  0/9 (0.00%)  2/7 (28.57%) 
Bone pain * 1  0/14 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Chest wall pain * 1  0/14 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Fibrosis deep connective tissue * 1  1/14 (7.14%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Generalized muscle weakness * 1  0/14 (0.00%)  2/20 (10.00%)  0/9 (0.00%)  1/7 (14.29%) 
Muscle weakness lower limb * 1  2/14 (14.29%)  0/20 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Musculoskeletal and connective tissue disorder - Other * 1  1/14 (7.14%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Myalgia * 1  1/14 (7.14%)  2/20 (10.00%)  1/9 (11.11%)  2/7 (28.57%) 
Neck pain * 1  1/14 (7.14%)  4/20 (20.00%)  0/9 (0.00%)  0/7 (0.00%) 
Pain in extremity * 1  5/14 (35.71%)  3/20 (15.00%)  1/9 (11.11%)  1/7 (14.29%) 
Scoliosis * 1  0/14 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Nervous system disorders         
Cognitive disturbance * 1  0/14 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Concentration impairment * 1  1/14 (7.14%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Dizziness * 1  2/14 (14.29%)  5/20 (25.00%)  3/9 (33.33%)  3/7 (42.86%) 
Dysgeusia * 1  3/14 (21.43%)  1/20 (5.00%)  1/9 (11.11%)  0/7 (0.00%) 
Facial nerve disorder * 1  0/14 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Headache * 1  2/14 (14.29%)  6/20 (30.00%)  4/9 (44.44%)  1/7 (14.29%) 
Intracranial hemorrhage * 1  0/14 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Memory impairment * 1  0/14 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Nervous system disorders - Other * 1  2/14 (14.29%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Olfactory nerve disorder * 1  0/14 (0.00%)  0/20 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Paresthesia * 1  0/14 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Peripheral motor neuropathy * 1  0/14 (0.00%)  3/20 (15.00%)  0/9 (0.00%)  1/7 (14.29%) 
Peripheral sensory neuropathy * 1  5/14 (35.71%)  9/20 (45.00%)  2/9 (22.22%)  4/7 (57.14%) 
Presyncope * 1  1/14 (7.14%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Syncope * 1  1/14 (7.14%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Tremor * 1  2/14 (14.29%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Psychiatric disorders         
Agitation * 1  1/14 (7.14%)  1/20 (5.00%)  0/9 (0.00%)  1/7 (14.29%) 
Anxiety * 1  3/14 (21.43%)  3/20 (15.00%)  2/9 (22.22%)  2/7 (28.57%) 
Depression * 1  3/14 (21.43%)  0/20 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Hallucinations * 1  0/14 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Insomnia * 1  7/14 (50.00%)  4/20 (20.00%)  3/9 (33.33%)  2/7 (28.57%) 
Psychiatric disorders - Other * 1  1/14 (7.14%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Restlessness * 1  2/14 (14.29%)  0/20 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Renal and urinary disorders         
Hematuria * 1  0/14 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Renal and urinary disorders - Other * 1  1/14 (7.14%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Urinary frequency * 1  3/14 (21.43%)  0/20 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Urinary retention * 1  1/14 (7.14%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Urinary urgency * 1  1/14 (7.14%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Reproductive system and breast disorders         
Erectile dysfunction * 1  1/14 (7.14%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Pelvic pain * 1  1/14 (7.14%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Perineal pain * 1  0/14 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Allergic rhinitis * 1  1/14 (7.14%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Cough * 1  12/14 (85.71%)  12/20 (60.00%)  4/9 (44.44%)  6/7 (85.71%) 
Dyspnea * 1  7/14 (50.00%)  9/20 (45.00%)  3/9 (33.33%)  4/7 (57.14%) 
Epistaxis * 1  4/14 (28.57%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Hiccups * 1  0/14 (0.00%)  0/20 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Hoarseness * 1  2/14 (14.29%)  2/20 (10.00%)  0/9 (0.00%)  1/7 (14.29%) 
Hypoxia * 1  1/14 (7.14%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Nasal congestion * 1  1/14 (7.14%)  2/20 (10.00%)  0/9 (0.00%)  1/7 (14.29%) 
Pleural effusion * 1  0/14 (0.00%)  1/20 (5.00%)  1/9 (11.11%)  1/7 (14.29%) 
Pleuritic pain * 1  0/14 (0.00%)  1/20 (5.00%)  1/9 (11.11%)  0/7 (0.00%) 
Pneumonitis * 1  1/14 (7.14%)  3/20 (15.00%)  2/9 (22.22%)  0/7 (0.00%) 
Postnasal drip * 1  1/14 (7.14%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Productive cough * 1  0/14 (0.00%)  2/20 (10.00%)  0/9 (0.00%)  2/7 (28.57%) 
Pulmonary fibrosis * 1  1/14 (7.14%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Respiratory, thoracic and mediastinal disorders - Other * 1  2/14 (14.29%)  0/20 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Sneezing * 1  1/14 (7.14%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Sore throat * 1  0/14 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  3/7 (42.86%) 
Voice alteration * 1  1/14 (7.14%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Wheezing * 1  2/14 (14.29%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Skin and subcutaneous tissue disorders         
Alopecia * 1  3/14 (21.43%)  7/20 (35.00%)  3/9 (33.33%)  4/7 (57.14%) 
Body odor * 1  1/14 (7.14%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Dry skin * 1  7/14 (50.00%)  3/20 (15.00%)  1/9 (11.11%)  0/7 (0.00%) 
Nail discoloration * 1  1/14 (7.14%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Pain of skin * 1  0/14 (0.00%)  0/20 (0.00%)  2/9 (22.22%)  0/7 (0.00%) 
Pruritus * 1  0/14 (0.00%)  4/20 (20.00%)  1/9 (11.11%)  1/7 (14.29%) 
Rash acneiform * 1  8/14 (57.14%)  3/20 (15.00%)  0/9 (0.00%)  0/7 (0.00%) 
Rash maculo-papular * 1  4/14 (28.57%)  1/20 (5.00%)  1/9 (11.11%)  0/7 (0.00%) 
Skin and subcutaneous tissue disorders - Other * 1  1/14 (7.14%)  2/20 (10.00%)  1/9 (11.11%)  2/7 (28.57%) 
Skin hyperpigmentation * 1  1/14 (7.14%)  0/20 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Skin hypopigmentation * 1  0/14 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Vascular disorders         
Hot flashes * 1  1/14 (7.14%)  2/20 (10.00%)  1/9 (11.11%)  0/7 (0.00%) 
Hypertension * 1  1/14 (7.14%)  4/20 (20.00%)  1/9 (11.11%)  2/7 (28.57%) 
Hypotension * 1  2/14 (14.29%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Superficial thrombophlebitis * 1  0/14 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/7 (0.00%) 
Thromboembolic event * 1  1/14 (7.14%)  2/20 (10.00%)  0/9 (0.00%)  2/7 (28.57%) 
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
This study stopped accrual early due to unmet targeted accrual goals with 59 subjects accrued out of 234 planned.
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.
Must obtain prior Sponsor approval.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Wendy Seiferheld
Organization: NRG Oncology
Phone: 215-574-3208
EMail: seiferheldw@nrgoncology.org
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01822496     History of Changes
Other Study ID Numbers: NCI-2013-00737
NCI-2013-00737 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
RTOG-1306 ( Other Identifier: NRG Oncology )
RTOG-1306 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA021661 ( U.S. NIH Grant/Contract )
First Submitted: April 1, 2013
First Posted: April 2, 2013
Results First Submitted: June 19, 2019
Results First Posted: August 5, 2019
Last Update Posted: August 5, 2019