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A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy With Concurrent and Consolidation Carboplatin/Paclitaxel +/- Cetuximab (IND #103444) in Patients With Stage IIIA/IIIB Non-Small Cell Lung Cancer

Phase 3
18 Years
Open (Enrolling)
Lung Cancer, Radiation Toxicity

Thank you

Trial Information

A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy With Concurrent and Consolidation Carboplatin/Paclitaxel +/- Cetuximab (IND #103444) in Patients With Stage IIIA/IIIB Non-Small Cell Lung Cancer



- To compare the overall survival of patients with newly diagnosed, unresectable stage
IIIA or IIIB non-small cell lung cancer treated with high- versus standard-dose
conformal radiotherapy with concurrent and consolidation chemotherapy comprising
carboplatin and paclitaxel.

- To compare the overall survival of patients treated with versus without cetuximab in
the setting of concurrent chemotherapy


- To compare progression-free survival and local-regional tumor control in patients
treated with these regimens.

- To compare the toxicity of high- versus standard-dose conformal radiotherapy and
concurrent chemotherapy with versus without cetuximab in these patients.

- To investigate the prognostic and predictive effects of gross tumor volume on overall
survival of patients treated with these regimens.

- To compare the quality of life of patients treated with these regimens.

- To correlate outcomes (i.e., survival, toxicity, or QOL) in these patients with
biological parameters.

- To analyze the predictive value of pre-treatment standardized uptake value (SUV) of PET
scan in predicting survival, distant metastasis, and local-regional control in patients
treated with these regimens.

- To explore biological markers to predict clinical outcome including survival, distant
metastasis, local-regional control, and QOL (including toxicity) in patients treated
with these regimens.

- To prospectively collect and bank tissue, blood, and urine specimens for future
biomarker analyses in predicting clinical outcome in patients treated with these

- To investigate associations between epidermal growth factor receptor (EGFR) expression
and toxicity, response, overall survival, and progression-free survival.

OUTLINE: This is a multicenter study. Patients are stratified according to PET staging (yes
vs no), radiotherapy technique (3-dimensional conformal radiotherapy vs intensity-modulated
radiotherapy), Zubrod performance status (0 vs 1), 4-dimensional CT planning utilization
(yes vs no), and histology (squamous vs non-squamous). Patients are randomized to 1 of 4
treatment arms. (Arms II and IV closed to accrual effective 6/17/11)

- Arm I: Patients undergo standard dose radiotherapy 5 days a week for 6 weeks for a
total of 60 Gy. Patients receive concurrent chemotherapy comprising paclitaxel IV over
1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Patients
also receive consolidation treatment of paclitaxel and carboplatin on days 64 and 85.
Treatment repeats in the absence of disease progression or unacceptable toxicity.

- Arm II: Patients undergo high-dose radiotherapy 5 days per week for 7.5 weeks. Patient
also receive concurrent paclitaxel and carboplatin as in Arm I on days 1, 8, 15, 22,
29, 36, and 43 . Patients also receive consolidation treatment comprising paclitaxel
and carboplatin on days 71 and 92. (closed to accrual effective 6/17/11)

- Arm III: Patients undergo standard-dose radiotherapy 5 days a week for 6 weeks for a
total of 60 Gy. Patients receive cetuximab in addition to concurrent chemotherapy as in
Arm I. Treatment continues with chemoradiation and cetuximab on days 8, 15, 22, 29, 36,
and 43. Patients receive consolidation treatment of cetuximab on days 50, 57, 64, 71,
78, 85, 92, 99, and 106 and paclitaxel and carboplatin on days 71 and 92.

- Arm IV: Patients undergo high-dose radiotherapy 5 days a week for 7.5 weeks for a total
of 74 Gy. Patients receive cetuximab in addition to concurrent chemotherapy as in Arm
I. Treatment continues with chemoradiation and cetuximab on days 8, 15, 22, 29, 36, 43,
and 50. Patients receive consolidation treatment of cetuximab on days 57, 64, 71, 78,
85, 92, 99, 106, and 113 and paclitaxel and carboplatin on days 78 and 99. (closed to
accrual effective 6/17/11) Patients may undergo tumor tissue, blood, and urine
collection periodically during study for tissue banking or biomarker correlative

Patients may undergo quality-of-life assessment at baseline and periodically during study.

After completion of study therapy, patients are followed periodically for 5 years and then
annually thereafter.

Inclusion Criteria


- Histologically or cytologically confirmed newly diagnosed non-small cell lung cancer

- Stage IIIA or IIIB disease

- N3 supraclavicular disease or contralateral hilar lymph node involvement
(i.e. greater than 1.5 cm on short axis or positive on PET scan) not

- N2 or N3 disease and an undetectable NSCLC primary tumor allowed

- Unresectable or inoperable disease

- No distant metastases

- Pleural effusion allowed provided effusion is minimal and none of the following
conditions are present:

- Cytologically positive pleural effusion detectable by CT scan and chest x-ray
(pleuracentesis required to confirm negative cytology of pleural fluid)

- Greater than minimal pleural effusions (minimal effusions not detectable by
chest x-ray and too small to tap safely are allowed)

- Exudative pleural effusions, regardless of cytology

- Malignant pleural effusion (T4 incurable disease)

- Measurable or evaluable disease


- Zubrod performance status 0-1

- Absolute neutrophil (ANC) ≥ 1,800 cells/mm³

- Platelet count ≥ 100,000 cells/mm³

- Hemoglobin ≥ 10.0 g/dL (transfusion or other intervention allowed)

- Creatinine normal OR creatinine clearance ≥ 60 mL/min

- Bilirubin normal

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times upper
limit of normal

- Pulmonary Function Test (PFTs) including forced expiratory volume at 1 sec. (FEV1) ≥
1.2 L/sec or ≥ 50% predicted (best value obtained prior to or after use of

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective protection

- No uncontrolled neuropathy ≥ grade 2

- Patients with post-obstructive pneumonia allowed

- No prior invasive malignancy, except nonmelanoma skin cancer, carcinoma in situ of
the breast, oral cavity, or cervix, unless the patient has been disease-free for the
past 3 years

- No prior severe infusion reaction to a monoclonal antibody

- No weight loss of ≥ 10% within the past 4 weeks

- No history of allergic reaction to paclitaxel or other taxanes, or to carboplatin

- No severe, active comorbidity, including any of the following:

- Unstable angina and/or congestive heart failure requiring hospitalization within
the past 6 months

- Transmural myocardial infarction within the past 6 months

- Acute bacterial or fungal infection requiring IV antibiotics at the time of
study entry

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or within past 30 days precluding study therapy

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects


- No significant history of uncontrolled cardiac disease, including any of the

- Uncontrolled hypertension

- unstable angina

- Myocardial infarction within the past 6 months

- Uncontrolled congestive heart failure

- Cardiomyopathy with decreased ejection fraction


- At least 3 weeks since prior exploratory thoracotomy (if performed)

- Prior systemic chemotherapy allowed, provided it was not given for NSCLC

- No prior therapy that specifically and directly targets the EGFR pathway

- No prior radiotherapy to the region of NSCLC that would result in overlap of
radiotherapy fields

- No concurrent white blood cell (WBC) growth factors (i.e., filgrastim [G-CSF] or
sargramostim [GM-CSF]) given during radiotherapy or prophylactically during
consolidation chemotherapy

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall (Failure: death from any cause) survival

Outcome Time Frame:

From randomization to date of death or last follow-up. Analysis occurs after 339 deaths have been reported.

Safety Issue:


Principal Investigator

Jeffrey Bradley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mallinckrodt Institute of Radiology at Washington University Medical Center


United States: Food and Drug Administration

Study ID:

RTOG 0617



Start Date:

November 2007

Completion Date:

Related Keywords:

  • Lung Cancer
  • Radiation Toxicity
  • radiation toxicity
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Radiation Injuries



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