Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Chemotherapy and Radiation Therapy With or Without Panitumumab in Treating Patients With Stage IIIA 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: NCT00979212
Recruitment Status : Active, not recruiting
First Posted : September 17, 2009
Results First Posted : August 16, 2016
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lung Cancer
Interventions Drug: panitumumab
Drug: carboplatin
Drug: paclitaxel
Procedure: surgery
Enrollment 71
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Induction CT+RT Induction CT+RT+Panitumumab
Hide Arm/Group Description Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin) Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
Period Title: Overall Study
Started 24 47
Completed 22 [1] 39 [1]
Not Completed 2 8
Reason Not Completed
Protocol Violation             1             8
No protocol therapy received             1             0
[1]
Subjects with data available for primary analysis are considered to have completed the study.
Arm/Group Title Induction CT+RT Induction CT+RT+Panitumumab Total
Hide Arm/Group Description Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin) Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin) Total of all reporting groups
Overall Number of Baseline Participants 22 39 61
Hide Baseline Analysis Population Description
All eligible patients receiving protocol treatment
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 22 participants 39 participants 61 participants
61
(51 to 77)
61
(32 to 78)
61
(32 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 39 participants 61 participants
Female
13
  59.1%
18
  46.2%
31
  50.8%
Male
9
  40.9%
21
  53.8%
30
  49.2%
1.Primary Outcome
Title Mediastinal Nodal Clearance After Completion of Induction Chemoradiotherapy With or Without Panitumumab.
Hide Description The assessment of whether mediastinal nodes which were involved at the time of study registration were clear of disease following induction chemoradiotherapy with or without panitumumab; the assessment is made at the time of surgery 4-6 weeks after chemoradiation. If surgery could not be performed, the patient was considered as not having had mediastinal nodal clearance.
Time Frame From date of randomization to time of protocol surgery, approximately 12 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started study treatment
Arm/Group Title Induction CT+RT Induction CT+RT+Panitumumab
Hide Arm/Group Description:
Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
Overall Number of Participants Analyzed 22 39
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
68.2
(45.1 to 86.1)
48.7
(32.4 to 65.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Induction CT+RT, Induction CT+RT+Panitumumab
Comments Null hypothesis (H0) was that the experimental treatment was not effective vs the alternative hypothesis (HA) that it was. H0: OR ≤ 1 vs. HA: OR > 1, where odds ratio (OR)= [p2*(1- p1)]/ [p1*(1- p2)], p1 denotes the mediastinal clearance rate (MCR) on Induction chemoradiation; p2 denotes the MCR on Induction chemoradiation + panitumumab. Fisher’s exact test was used to compare the MCRs; the 95% confidence interval was calculated using Clopper-Pearson method. 97 patients were required.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.96
Comments One-sided test at significance level of 0.05
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival
Hide Description Survival time was calculated from the date of randomization to the date of death from any cause or the date of last follow-up. The Kaplan-Meier method was used to estimate the overall survival rates. One-year survival rates were estimated, not compared.
Time Frame Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started study treatment
Arm/Group Title Induction CT+RT Induction CT+RT+Panitumumab
Hide Arm/Group Description:
Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
Overall Number of Participants Analyzed 22 39
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
94.4
(66.6 to 99.2)
89.1
(73.5 to 95.8)
3.Secondary Outcome
Title Patterns of First Failure
Hide Description The first failure site will be tabulated, not compared.
Time Frame Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started study treatment
Arm/Group Title Induction CT+RT Induction CT+RT+Panitumumab
Hide Arm/Group Description:
Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
Overall Number of Participants Analyzed 22 39
Measure Type: Number
Unit of Measure: participants
Alive, no failure 15 20
Dead, no failure 1 3
Distant failure only 4 9
Local and distant failure 1 2
Local and regional failure 0 1
Local, regional, and distant failure 0 2
Regional failure only 1 2
4.Secondary Outcome
Title Percentage of Patients With Grade 3 or Higher Acute and Late Adverse Events
Hide Description Adverse events 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. Does not include surgical morbidities. An acute adverse event is defined as any grade 3 or worse toxicity occurring during protocol treatment and within 30 days from the end of protocol treatment that is possibly, probably, or definitely related to treatment. Acute adverse events are any adverse events occurring within 30 days of the end of all protocol treatment. Late adverse events are any adverse events occurring after 30 days after the end of all protocol treatment.
Time Frame Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started study treatment
Arm/Group Title Induction CT+RT Induction CT+RT+Panitumumab
Hide Arm/Group Description:
Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
Overall Number of Participants Analyzed 22 39
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Acute
81.8
(59.7 to 94.8)
69.2
(52.4 to 83.0)
Late
30.3
(11.9 to 54.3)
15.2
(5.1 to 31.9)
5.Secondary Outcome
Title Surgical Morbidities in Patients With Resectable Disease at Reassessment
Hide Description A surgical morbidity is any toxicity occurring within 30 days of protocol surgery, as evaluated using CTCAE v4.0. Rates of grade 3 and higher surgical morbidity were calculated; the rates across arms were not compared.
Time Frame From date of surgery to 30 days following surgery.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started study treatment and received protocol surgery
Arm/Group Title Induction CT+RT Induction CT+RT+Panitumumab
Hide Arm/Group Description:
Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
Overall Number of Participants Analyzed 19 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
42.1
(20.3 to 66.5)
20
(7.7 to 38.6)
6.Secondary Outcome
Title Ability of FDG-PET/CT Scan Data to Predict Outcome
Hide Description [Not Specified]
Time Frame Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study.
Hide Outcome Measure Data
Hide Analysis Population Description
FDG-PET/CT scan data was not obtained and therefore this outcome measure cannot be reported.
Arm/Group Title Induction CT+RT Induction CT+RT+Panitumumab
Hide Arm/Group Description:
Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Response Rate
Hide Description Patients are assessed for best response to protocol treatment using the RECIST criteria. The response rate was calculated as the number of patients who have a complete response (CR) or partial response (PR) divided by the total number of analyzable patients at completion of induction chemoradiation +/- panitumumab and prior to anticipated surgery in each arm. Patients without a documented assessment are considered as not having a CR or PR. Rates are not compared across arms.
Time Frame From date of randomization to time of protocol surgery, approximately 12 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started study treatment
Arm/Group Title Induction CT+RT Induction CT+RT+Panitumumab
Hide Arm/Group Description:
Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
Overall Number of Participants Analyzed 22 39
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
77.3
(54.6 to 92.2)
61.5
(44.6 to 76.6)
Time Frame [Not Specified]
Adverse Event Reporting Description Subjects experiencing more than one of a given adverse event are counted only once for that adverse event. Note, with yearly update of adverse events, eligibility determination of one patient changed and as a result the number at risk shown for adverse events now differs from the Participant Flow table which was entered previously.
 
Arm/Group Title Induction CT+RT Induction CT+RT+Panitumumab
Hide Arm/Group Description Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin) Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
All-Cause Mortality
Induction CT+RT Induction CT+RT+Panitumumab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Induction CT+RT Induction CT+RT+Panitumumab
Affected / at Risk (%) Affected / at Risk (%)
Total   8/22 (36.36%)   20/38 (52.63%) 
Blood and lymphatic system disorders     
Anemia * 1  1/22 (4.55%)  0/38 (0.00%) 
Cardiac disorders     
Atrial fibrillation  1  0/22 (0.00%)  2/38 (5.26%) 
Cardiac arrest * 1  0/22 (0.00%)  1/38 (2.63%) 
Gastrointestinal disorders     
Diarrhea * 1  2/22 (9.09%)  2/38 (5.26%) 
Dysphagia * 1  0/22 (0.00%)  1/38 (2.63%) 
Esophagitis * 1  1/22 (4.55%)  2/38 (5.26%) 
Gastritis * 1  0/22 (0.00%)  1/38 (2.63%) 
Hemorrhoidal hemorrhage * 1  0/22 (0.00%)  1/38 (2.63%) 
Ileus * 1  1/22 (4.55%)  0/38 (0.00%) 
Nausea * 1  1/22 (4.55%)  2/38 (5.26%) 
Rectal hemorrhage * 1  0/22 (0.00%)  1/38 (2.63%) 
Vomiting * 1  1/22 (4.55%)  2/38 (5.26%) 
General disorders     
Fatigue * 1  0/22 (0.00%)  1/38 (2.63%) 
Infusion related reaction * 1  0/22 (0.00%)  1/38 (2.63%) 
Immune system disorders     
Anaphylaxis * 1  0/22 (0.00%)  1/38 (2.63%) 
Infections and infestations     
Lung infection  1  2/22 (9.09%)  5/38 (13.16%) 
Pleural infection  1  0/22 (0.00%)  1/38 (2.63%) 
Sepsis * 1  0/22 (0.00%)  3/38 (7.89%) 
Skin infection * 1  0/22 (0.00%)  1/38 (2.63%) 
Upper respiratory infection * 1  0/22 (0.00%)  1/38 (2.63%) 
Urinary tract infection * 1  0/22 (0.00%)  1/38 (2.63%) 
Wound infection * 1  0/22 (0.00%)  1/38 (2.63%) 
Injury, poisoning and procedural complications     
Postoperative thoracic procedure complication * 1  0/22 (0.00%)  1/38 (2.63%) 
Investigations     
Electrocardiogram QT corrected interval prolonged * 1  0/22 (0.00%)  1/38 (2.63%) 
Lymphocyte count decreased * 1  1/22 (4.55%)  2/38 (5.26%) 
Neutrophil count decreased * 1  1/22 (4.55%)  2/38 (5.26%) 
White blood cell decreased * 1  0/22 (0.00%)  1/38 (2.63%) 
Metabolism and nutrition disorders     
Dehydration * 1  0/22 (0.00%)  1/38 (2.63%) 
Musculoskeletal and connective tissue disorders     
Myalgia * 1  0/22 (0.00%)  1/38 (2.63%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Treatment related secondary malignancy * 1  0/22 (0.00%)  1/38 (2.63%) 
Nervous system disorders     
Nervous system disorders - Other * 1  0/22 (0.00%)  1/38 (2.63%) 
Peripheral sensory neuropathy * 1  1/22 (4.55%)  0/38 (0.00%) 
Recurrent laryngeal nerve palsy * 1  1/22 (4.55%)  0/38 (0.00%) 
Stroke * 1  1/22 (4.55%)  0/38 (0.00%) 
Renal and urinary disorders     
Acute kidney injury * 1  0/22 (0.00%)  1/38 (2.63%) 
Urinary retention * 1  0/22 (0.00%)  1/38 (2.63%) 
Respiratory, thoracic and mediastinal disorders     
Aspiration * 1  0/22 (0.00%)  1/38 (2.63%) 
Bronchial stricture * 1  0/22 (0.00%)  1/38 (2.63%) 
Bronchopleural fistula  1  0/22 (0.00%)  2/38 (5.26%) 
Bronchopulmonary hemorrhage * 1  0/22 (0.00%)  1/38 (2.63%) 
Dyspnea * 1  1/22 (4.55%)  2/38 (5.26%) 
Hypoxia * 1  0/22 (0.00%)  1/38 (2.63%) 
Pleural hemorrhage * 1  1/22 (4.55%)  0/38 (0.00%) 
Pleuritic pain * 1  1/22 (4.55%)  1/38 (2.63%) 
Pneumonitis * 1  0/22 (0.00%)  3/38 (7.89%) 
Pulmonary edema * 1  0/22 (0.00%)  1/38 (2.63%) 
Respiratory failure * 1  0/22 (0.00%)  2/38 (5.26%) 
Skin and subcutaneous tissue disorders     
Rash maculo-papular * 1  0/22 (0.00%)  1/38 (2.63%) 
Vascular disorders     
Thromboembolic event  1  2/22 (9.09%)  0/38 (0.00%) 
Indicates events were collected by systematic assessment
*
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 5%
Induction CT+RT Induction CT+RT+Panitumumab
Affected / at Risk (%) Affected / at Risk (%)
Total   22/22 (100.00%)   37/38 (97.37%) 
Blood and lymphatic system disorders     
Anemia * 1  13/22 (59.09%)  20/38 (52.63%) 
Cardiac disorders     
Atrial fibrillation  1  7/22 (31.82%)  4/38 (10.53%) 
Atrial flutter  1  2/22 (9.09%)  0/38 (0.00%) 
Chest pain - cardiac * 1  2/22 (9.09%)  0/38 (0.00%) 
Sinus tachycardia * 1  5/22 (22.73%)  2/38 (5.26%) 
Ventricular arrhythmia  1  3/22 (13.64%)  0/38 (0.00%) 
Gastrointestinal disorders     
Constipation * 1  6/22 (27.27%)  17/38 (44.74%) 
Diarrhea * 1  7/22 (31.82%)  7/38 (18.42%) 
Dyspepsia * 1  7/22 (31.82%)  11/38 (28.95%) 
Dysphagia * 1  9/22 (40.91%)  17/38 (44.74%) 
Esophagitis * 1  8/22 (36.36%)  15/38 (39.47%) 
Gastroesophageal reflux disease * 1  2/22 (9.09%)  4/38 (10.53%) 
Nausea * 1  13/22 (59.09%)  19/38 (50.00%) 
Vomiting * 1  6/22 (27.27%)  7/38 (18.42%) 
General disorders     
Chills * 1  3/22 (13.64%)  4/38 (10.53%) 
Fatigue * 1  20/22 (90.91%)  30/38 (78.95%) 
Fever * 1  5/22 (22.73%)  6/38 (15.79%) 
Flu like symptoms * 1  2/22 (9.09%)  0/38 (0.00%) 
Non-cardiac chest pain * 1  3/22 (13.64%)  3/38 (7.89%) 
Pain * 1  8/22 (36.36%)  11/38 (28.95%) 
Infections and infestations     
Infections and infestations - Other * 1  2/22 (9.09%)  0/38 (0.00%) 
Lung infection  1  4/22 (18.18%)  4/38 (10.53%) 
Urinary tract infection * 1  3/22 (13.64%)  2/38 (5.26%) 
Injury, poisoning and procedural complications     
Dermatitis radiation * 1  6/22 (27.27%)  3/38 (7.89%) 
Investigations     
Alkaline phosphatase increased * 1  4/22 (18.18%)  4/38 (10.53%) 
Creatinine increased * 1  2/22 (9.09%)  2/38 (5.26%) 
Lymphocyte count decreased * 1  9/22 (40.91%)  10/38 (26.32%) 
Lymphocyte count increased * 1  2/22 (9.09%)  0/38 (0.00%) 
Neutrophil count decreased * 1  7/22 (31.82%)  9/38 (23.68%) 
Platelet count decreased * 1  10/22 (45.45%)  8/38 (21.05%) 
Weight loss * 1  6/22 (27.27%)  11/38 (28.95%) 
White blood cell decreased * 1  12/22 (54.55%)  12/38 (31.58%) 
Metabolism and nutrition disorders     
Anorexia * 1  13/22 (59.09%)  11/38 (28.95%) 
Glucose intolerance * 1  2/22 (9.09%)  1/38 (2.63%) 
Hyperglycemia * 1  8/22 (36.36%)  12/38 (31.58%) 
Hypoalbuminemia * 1  3/22 (13.64%)  7/38 (18.42%) 
Hypocalcemia * 1  4/22 (18.18%)  8/38 (21.05%) 
Hypomagnesemia * 1  4/22 (18.18%)  9/38 (23.68%) 
Hyponatremia * 1  4/22 (18.18%)  4/38 (10.53%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  3/22 (13.64%)  4/38 (10.53%) 
Back pain * 1  6/22 (27.27%)  3/38 (7.89%) 
Chest wall pain * 1  6/22 (27.27%)  2/38 (5.26%) 
Generalized muscle weakness * 1  3/22 (13.64%)  2/38 (5.26%) 
Musculoskeletal and connective tissue disorder - Other * 1  2/22 (9.09%)  3/38 (7.89%) 
Myalgia * 1  2/22 (9.09%)  3/38 (7.89%) 
Pain in extremity * 1  3/22 (13.64%)  3/38 (7.89%) 
Nervous system disorders     
Dizziness * 1  6/22 (27.27%)  5/38 (13.16%) 
Dysgeusia * 1  4/22 (18.18%)  6/38 (15.79%) 
Headache * 1  4/22 (18.18%)  5/38 (13.16%) 
Paresthesia * 1  4/22 (18.18%)  3/38 (7.89%) 
Peripheral sensory neuropathy * 1  6/22 (27.27%)  11/38 (28.95%) 
Psychiatric disorders     
Anxiety * 1  3/22 (13.64%)  5/38 (13.16%) 
Depression * 1  4/22 (18.18%)  3/38 (7.89%) 
Insomnia * 1  5/22 (22.73%)  6/38 (15.79%) 
Renal and urinary disorders     
Urinary retention * 1  2/22 (9.09%)  1/38 (2.63%) 
Respiratory, thoracic and mediastinal disorders     
Atelectasis  1  9/22 (40.91%)  3/38 (7.89%) 
Chylothorax  1  3/22 (13.64%)  0/38 (0.00%) 
Cough * 1  9/22 (40.91%)  14/38 (36.84%) 
Dyspnea * 1  16/22 (72.73%)  17/38 (44.74%) 
Hoarseness * 1  2/22 (9.09%)  1/38 (2.63%) 
Pleural effusion  1  10/22 (45.45%)  5/38 (13.16%) 
Pleuritic pain * 1  3/22 (13.64%)  0/38 (0.00%) 
Pneumothorax  1  7/22 (31.82%)  3/38 (7.89%) 
Productive cough * 1  4/22 (18.18%)  2/38 (5.26%) 
Sore throat * 1  3/22 (13.64%)  3/38 (7.89%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  6/22 (27.27%)  12/38 (31.58%) 
Hyperhidrosis * 1  2/22 (9.09%)  0/38 (0.00%) 
Rash maculo-papular * 1  3/22 (13.64%)  13/38 (34.21%) 
Vascular disorders     
Hypertension * 1  2/22 (9.09%)  1/38 (2.63%) 
Hypotension * 1  4/22 (18.18%)  3/38 (7.89%) 
Thromboembolic event  1  2/22 (9.09%)  0/38 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Following a recommendation on July 13, 2015 by the NRG Data Monitoring Committee accrual was halted early after accruing only 71 of 97 patients due to unexpectedly high rates of grade 5 toxicity on the panitumumab arm.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
Results Point of Contact
Name/Title: Wendy Seiferheld, M.S.
Organization: NRG Oncology
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00979212     History of Changes
Other Study ID Numbers: RTOG-0839
CDR0000654690
NCI-2011-01970 ( Registry Identifier: Clinical Trials Reporting Program (CTRP) )
First Submitted: September 16, 2009
First Posted: September 17, 2009
Results First Submitted: June 30, 2016
Results First Posted: August 16, 2016
Last Update Posted: May 7, 2019