A PHASE III COMPARISON BETWEEN CONCURRENT CHEMOTHERAPY PLUS RADIOTHERAPY AND CONCURRENT CHEMOTHERAPY PLUS RADIOTHERAPY FOLLOWED BY SURGICAL RESECTION FOR STAGE IIIA (N2) NON-SMALL CELL LUNG CANCER
- 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
- Compare the patterns of local and distant failure in patients treated with these
- 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
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.
Allocation: Randomized, Primary Purpose: Treatment
Median (2-year) survival
David S. Ettinger, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
|Indiana University Cancer Center||Indianapolis, Indiana 46202-5265|
|CCOP - Ann Arbor Regional||Ann Arbor, Michigan 48106|
|University of Rochester Cancer Center||Rochester, New York 14642|
|Ireland Cancer Center||Cleveland, Ohio 44106-5065|
|CCOP - Missouri Valley Cancer Consortium||Omaha, Nebraska 68131|
|CCOP - Carle Cancer Center||Urbana, Illinois 61801|
|Veterans Affairs Medical Center - Indianapolis (Roudebush)||Indianapolis, Indiana 46202|
|Hahnemann University Hospital||Philadelphia, Pennsylvania 19102-1192|
|University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15213|
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|CCOP - Cedar Rapids Oncology Project||Cedar Rapids, Iowa 52403-1206|
|CCOP - Toledo Community Hospital Oncology Program||Toledo, Ohio 43623-3456|
|Medical College of Wisconsin||Milwaukee, Wisconsin 53226|
|Veterans Affairs Medical Center - Milwaukee (Zablocki)||Milwaukee, Wisconsin 53295|
|CCOP - Green Bay||Green Bay, Wisconsin 54301|