Chemotherapy Plus Radiation Therapy With or Without Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer
- Conditions
- Lung Cancer
- Interventions
- Registration Number
- NCT00002550
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known if chemotherapy plus radiation therapy is more effective with or without surgery for lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of combining cisplatin, etoposide, and radiation therapy with or without surgery in treating patients who have stage IIIA non-small cell lung cancer.
- Detailed Description
OBJECTIVES:
Primary
* Compare the progression-free survival, median (2-year) survival, and long-term (5-year) survival in patients with newly diagnosed, stage IIIA (N2) non-small cell lung cancer treated with radiotherapy concurrently with cisplatin and etoposide with or without surgical resection.
Secondary
* Compare the patterns of local and distant failure in patients treated with these regimens.
* Determine the relationship of tobacco use, alcohol use, and diet with toxicity of these regimens and outcome in both men and women.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by contralateral mediastinal sampling or biopsy (yes vs no), tumor stage (T1 vs T2 vs T3), and performance status (70-80% vs 90-100%). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive induction with cisplatin IV over 1 hour on days 1 and 8 and etoposide IV over 1 hour on days 1-5. Treatment continues every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning within 24 hours of the first dose of chemotherapy, patients undergo induction radiotherapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity. Patients without local progression or distant metastases at 2-4 weeks after completion of course 2 undergo resection approximately 3-5 weeks after completion of course 2. All visible, accessible bronchopulmonary, hilar, and mediastinal lymph nodes are excised. The choice of surgical procedure (thoracotomy, lobectomy, or pneumonectomy with en bloc resection of tumor extending into the parietal pleura, chest wall, pericardium, or diaphragm) is at the discretion of the surgeon. Patients who undergo resection receive 2 additional courses of chemotherapy alone beginning 4-6 weeks postoperatively. Patients with unresectable disease or who are medically unfit for or refuse resection receive 2 additional courses of chemotherapy alone beginning immediately after completion of course 2.
* Arm II: Patients undergo induction chemoradiotherapy as in arm I but do not undergo resection. Patients without local progression or distant metastases within 1 week before anticipated completion of induction radiotherapy receive 2 additional courses of chemotherapy beginning immediately after completion of course 2. Patients without local or distant progression after completion of course 4 undergo boost radiotherapy for 8 days.
Patients are followed every 2 months for 1 year, every 3 months for 2 years, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 510 patients will be accrued for this study within 4.9 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 429
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RT + chemotherapy followed by surgery + chemotherapy radiation therapy Induction radiation therapy (RT) + concurrent induction chemotherapy followed by surgery and additional chemotherapy RT + chemotherapy followed by chemotherapy + RT radiation therapy Induction RT + concurrent induction chemotherapy followed by additional chemotherapy + RT RT + chemotherapy followed by surgery + chemotherapy conventional surgery Induction radiation therapy (RT) + concurrent induction chemotherapy followed by surgery and additional chemotherapy RT + chemotherapy followed by surgery + chemotherapy etoposide Induction radiation therapy (RT) + concurrent induction chemotherapy followed by surgery and additional chemotherapy RT + chemotherapy followed by surgery + chemotherapy cisplatin Induction radiation therapy (RT) + concurrent induction chemotherapy followed by surgery and additional chemotherapy RT + chemotherapy followed by chemotherapy + RT cisplatin Induction RT + concurrent induction chemotherapy followed by additional chemotherapy + RT RT + chemotherapy followed by chemotherapy + RT etoposide Induction RT + concurrent induction chemotherapy followed by additional chemotherapy + RT
- Primary Outcome Measures
Name Time Method Median overall survival From randomization to date of death or last follow-up. Analysis occurs after patients have been potentially followed for 2.5 years.
- Secondary Outcome Measures
Name Time Method Median Progression-free survival From randomization to date of death or last follow-up. Analysis occurs after patients have been potentially followed for 2.5 years. Patterns of local and distant failure From randomization to date of failure (local, regional or distant progression). Analysis occurs after patients have been potentially followed for 2.5 years.
Trial Locations
- Locations (16)
University of Pittsburgh Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
🇺🇸Indianapolis, Indiana, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
🇺🇸Milwaukee, Wisconsin, United States
Pretoria Academic Hospitals
🇿🇦Pretoria, South Africa
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States
CCOP - Green Bay
🇺🇸Green Bay, Wisconsin, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Hahnemann University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
University of Rochester Cancer Center
🇺🇸Rochester, New York, United States
CCOP - Toledo Community Hospital Oncology Program
🇺🇸Toledo, Ohio, United States