Chemotherapy Plus Radiation Therapy With or Without Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00002550|
Recruitment Status : Completed
First Posted : April 10, 2003
Last Update Posted : November 17, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: cisplatin Drug: etoposide Procedure: conventional surgery Radiation: radiation therapy||Phase 3|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||429 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||March 1994|
|Actual Primary Completion Date :||June 2004|
|Actual Study Completion Date :||November 2013|
Experimental: RT + chemotherapy followed by surgery + chemotherapy
Induction radiation therapy (RT) + concurrent induction chemotherapy followed by surgery and additional chemotherapy
Procedure: conventional surgery
Radiation: radiation therapy
Active Comparator: RT + chemotherapy followed by chemotherapy + RT
Induction RT + concurrent induction chemotherapy followed by additional chemotherapy + RT
Radiation: radiation therapy
- Median overall survival [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after patients have been potentially followed for 2.5 years. ]
- Median Progression-free survival [ Time Frame: 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 [ Time Frame: From randomization to date of failure (local, regional or distant progression). Analysis occurs after patients have been potentially followed for 2.5 years. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002550
|United States, Illinois|
|CCOP - Carle Cancer Center|
|Urbana, Illinois, United States, 61801|
|United States, Indiana|
|Indiana University Cancer Center|
|Indianapolis, Indiana, United States, 46202-5289|
|Veterans Affairs Medical Center - Indianapolis (Roudebush)|
|Indianapolis, Indiana, United States, 46202|
|United States, Iowa|
|CCOP - Cedar Rapids Oncology Project|
|Cedar Rapids, Iowa, United States, 52403-1206|
|United States, Michigan|
|CCOP - Ann Arbor Regional|
|Ann Arbor, Michigan, United States, 48106|
|United States, Nebraska|
|CCOP - Missouri Valley Cancer Consortium|
|Omaha, Nebraska, United States, 68106|
|United States, New York|
|University of Rochester Cancer Center|
|Rochester, New York, United States, 14642|
|United States, Ohio|
|Ireland Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|CCOP - Toledo Community Hospital Oncology Program|
|Toledo, Ohio, United States, 43623-3456|
|United States, Pennsylvania|
|Hahnemann University Hospital|
|Philadelphia, Pennsylvania, United States, 19102-1192|
|University of Pittsburgh Cancer Institute|
|Pittsburgh, Pennsylvania, United States, 15213-3489|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|United States, Wisconsin|
|CCOP - Green Bay|
|Green Bay, Wisconsin, United States, 54301|
|Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Veterans Affairs Medical Center - Milwaukee (Zablocki)|
|Milwaukee, Wisconsin, United States, 53295|
|Pretoria Academic Hospitals|
|Pretoria, South Africa, 0001|
|Study Chair:||David S. Ettinger, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Principal Investigator:||Kathy S. Albain, MD||Loyola University|
|Study Chair:||David H. Johnson, MD||Vanderbilt-Ingram Cancer Center|
|Study Chair:||Bruce E. Johnson, MD||Dana-Farber Cancer Institute|
|Study Chair:||Mark R. Green, MD||Medical University of South Carolina|
|Study Chair:||Robert C. Miller, MD||Mayo Clinic|
|Study Chair:||Yvon Cormier, MD||L'Hopital Laval|