Chemotherapy or Observation in Treating Patients With Early Stage Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Interventions
- Procedure: standard follow-up care
- Registration Number
- NCT00863512
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as vinorelbine, cisplatin, docetaxel, gemcitabine, and pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether chemotherapy is more effective than observation in treating patients who have undergone surgery for stage I non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying four chemotherapy regimens to see how well they work compared with observation in treating patients with early stage non-small cell lung cancer.
- Detailed Description
OBJECTIVES:
Primary
* To determine the potential overall survival benefit of adjuvant chemotherapy in patients with early stage non-small cell lung cancer (NSCLC) randomized to chemotherapy compared to those randomized to the present standard of care (observation).
* To collect and process high-quality fresh frozen lung cancer tumor tissue for gene expression array generation from multiple institutions.
Secondary
* To evaluate selected genomic-based lung cancer prognostic models using data from the patients randomized to observation after resection.
* To characterize the rate of chemotherapy toxicity for the different chemotherapy treatment regimens.
* To assess quality of life (QOL) in early stage patients periodically after resection for NSCLC.
* To examine the impact of chemotherapy on QOL for patients receiving chemotherapy, as compared to patients in the observation arm.
OUTLINE: This is a multicenter study. Patients are stratified according to pathologic stage (I vs II) and ECOG performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms within 12 weeks after surgery.
All patients undergo complete resection of disease (i.e., lobectomy, sleeve lobectomy, bi-lobectomy, or pneumonectomy, but not segmentectomy or wedge resection).
* Arm I: Patients receive 1 of 3 chemotherapy regimens. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
* Regimen 1: Patients receive vinorelbine ditartrate IV over 10 minutes on days 1 and 8 and cisplatin IV over 60 minutes on day 1.
* Regimen 2: Patients receive docetaxel IV over 60 minutes and cisplatin IV over 60 minutes on day 1.
* Regimen 3: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 60 minutes on day 1.
* Regimen 4: Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 60 minutes on day 1.
* Arm II: Patients receive standard care (observation). Tissue obtained at surgery is examined by RNA microarray analysis. A Lung Metagene Score (LMS) is determined for each patient and correlated with survival and response.
After completion of study treatment, patients are followed every 6 months for 5 years and then once a year for 7 years.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 34
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I gemcitabine hydrochloride Patients receive cisplatin IV on day 1 and vinorelbine ditartrate IV on days 1 and 8 OR docetaxel IV and cytarabine IV on day 1 OR gemcitabine hydrochloride IV on days 1 and 8 and cytarabine IV on day 1 OR pemetrexed disodium IV and cisplatin IV on day 1.. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Arm II standard follow-up care Patients receive standard care (observation). Arm I pemetrexed disodium Patients receive cisplatin IV on day 1 and vinorelbine ditartrate IV on days 1 and 8 OR docetaxel IV and cytarabine IV on day 1 OR gemcitabine hydrochloride IV on days 1 and 8 and cytarabine IV on day 1 OR pemetrexed disodium IV and cisplatin IV on day 1.. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Arm I vinorelbine tartrate Patients receive cisplatin IV on day 1 and vinorelbine ditartrate IV on days 1 and 8 OR docetaxel IV and cytarabine IV on day 1 OR gemcitabine hydrochloride IV on days 1 and 8 and cytarabine IV on day 1 OR pemetrexed disodium IV and cisplatin IV on day 1.. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Arm I cisplatin Patients receive cisplatin IV on day 1 and vinorelbine ditartrate IV on days 1 and 8 OR docetaxel IV and cytarabine IV on day 1 OR gemcitabine hydrochloride IV on days 1 and 8 and cytarabine IV on day 1 OR pemetrexed disodium IV and cisplatin IV on day 1.. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Arm I docetaxel Patients receive cisplatin IV on day 1 and vinorelbine ditartrate IV on days 1 and 8 OR docetaxel IV and cytarabine IV on day 1 OR gemcitabine hydrochloride IV on days 1 and 8 and cytarabine IV on day 1 OR pemetrexed disodium IV and cisplatin IV on day 1.. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
- Primary Outcome Measures
Name Time Method Overall Survival Up to 12 years Overall survival (OS) is defined as the time between formal registration and death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (93)
Good Samaritan Cancer Center
🇺🇸Puyallup, Washington, United States
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
🇺🇸Baltimore, Maryland, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
Resurrection Medical Center
🇺🇸Chicago, Illinois, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Michiana Hematology Oncology PC - La Porte
🇺🇸Westville, Indiana, United States
Michiana Hematology Oncology PC - Niles
🇺🇸Niles, Michigan, United States
UAB Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Allenmore Hospital
🇺🇸Tacoma, Washington, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center
🇺🇸Omaha, Nebraska, United States
Creighton University Medical Center
🇺🇸Omaha, Nebraska, United States
Immanuel Medical Center
🇺🇸Omaha, Nebraska, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
Glendale Memorial Hospital Comprehensive Cancer Center
🇺🇸Glendale, California, United States
Regional Medical Center
🇺🇸Anniston, Alabama, United States
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
🇺🇸Pomona, California, United States
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
🇺🇸Burbank, California, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Helen and Harry Gray Cancer Center at Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
🇺🇸Fort Lauderdale, Florida, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
🇺🇸Jupiter, Florida, United States
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
🇺🇸Savannah, Georgia, United States
Michiana Hematology-Oncology, PC - Elkhart
🇺🇸Elkhart, Indiana, United States
Elkhart Clinic, LLC
🇺🇸Elkhart, Indiana, United States
Elkhart General Hospital
🇺🇸Elkhart, Indiana, United States
Howard Community Hospital
🇺🇸Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
🇺🇸La Porte, Indiana, United States
Saint Joseph Regional Medical Center
🇺🇸Mishawaka, Indiana, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Michiana Hematology-Oncology, PC - South Bend
🇺🇸Mishawaka, Indiana, United States
Michiana Hematology Oncology PC - Plymouth
🇺🇸Plymouth, Indiana, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
Cedar Rapids Oncology Associates
🇺🇸Cedar Rapids, Iowa, United States
Lucille P. Markey Cancer Center at University of Kentucky
🇺🇸Lexington, Kentucky, United States
Mercy Regional Cancer Center at Mercy Medical Center
🇺🇸Cedar Rapids, Iowa, United States
Central Baptist Hospital
🇺🇸Lexington, Kentucky, United States
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
🇺🇸Scarborough, Maine, United States
Mary Bird Perkins Cancer Center - Baton Rouge
🇺🇸Baton Rouge, Louisiana, United States
Cancer Institute at St. Joseph Medical Center
🇺🇸Towson, Maryland, United States
Greater Baltimore Medical Center Cancer Center
🇺🇸Baltimore, Maryland, United States
Green Bay Oncology, Limited - Escanaba
🇺🇸Escanaba, Michigan, United States
Dana-Farber/Brigham and Women's Cancer Center
🇺🇸Boston, Massachusetts, United States
Dickinson County Healthcare System
🇺🇸Iron Mountain, Michigan, United States
Newton-Wellesley Hospital
🇺🇸Newton, Massachusetts, United States
Borgess Medical Center
🇺🇸Kalamazoo, Michigan, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
William Beaumont Hospital - Royal Oak Campus
🇺🇸Royal Oak, Michigan, United States
Lakeside Cancer Specialists, PLLC
🇺🇸Saint Joseph, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph
🇺🇸St. Joseph, Michigan, United States
Cancer Resource Center - Lincoln
🇺🇸Lincoln, Nebraska, United States
Methodist Estabrook Cancer Center
🇺🇸Omaha, Nebraska, United States
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
🇺🇸Concord, New Hampshire, United States
Saint Francis Hospital Cancer Center
🇺🇸Poughkeepsie, New York, United States
New Hampshire Oncology - Hematology, PA - Hooksett
🇺🇸Hooksett, New Hampshire, United States
Faxton Regional Cancer Center
🇺🇸Utica, New York, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
🇺🇸Allentown, Pennsylvania, United States
Mercy Cancer Center at Mercy Medical Center
🇺🇸Canton, Ohio, United States
Kinston Medical Specialists
🇺🇸Kinston, North Carolina, United States
St. Luke's Cancer Network at St. Luke's Hospital
🇺🇸Bethlehem, Pennsylvania, United States
Jameson Memorial Hospital - North Campus
🇺🇸New Castle, Pennsylvania, United States
Allegheny Cancer Center at Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
UPMC Cancer Centers
🇺🇸Pittsburgh, Pennsylvania, United States
Providence St. Peter Hospital Regional Cancer Center
🇺🇸Olympia, Washington, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
Green Bay Oncology, Limited at St. Mary's Hospital
🇺🇸Green Bay, Wisconsin, United States
Holy Family Memorial Medical Center Cancer Care Center
🇺🇸Manitowoc, Wisconsin, United States
St. Mary's Hospital Medical Center - Green Bay
🇺🇸Green Bay, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center
🇺🇸Marinette, Wisconsin, United States
St. Nicholas Hospital
🇺🇸Sheboygan, Wisconsin, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Easton Regional Cancer Center at Easton Hospital
🇺🇸Easton, Pennsylvania, United States
Providence Centralia Hospital
🇺🇸Centralia, Washington, United States
Memorial Cancer Institute at Memorial Regional Hospital
🇺🇸Hollywood, Florida, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
🇺🇸Tulsa, Oklahoma, United States
University of Virginia Cancer Center
🇺🇸Charlottesville, Virginia, United States
Franciscan Cancer Center at St. Joseph Medical Center
🇺🇸Tacoma, Washington, United States
Lynchburg Hematology-Oncology Clinic
🇺🇸Lynchburg, Virginia, United States
MultiCare Regional Cancer Center at Tacoma General Hospital
🇺🇸Tacoma, Washington, United States
St. Francis Hospital
🇺🇸Federal Way, Washington, United States
St. Vincent's Hospital - Melbourne
🇦🇺Fitzroy, Victoria, Australia
St. Clare Hospital
🇺🇸Tacoma, Washington, United States
Green Bay Oncology, Limited - Sturgeon Bay
🇺🇸Sturgeon Bay, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
Green Bay Oncology, Limited - Oconto Falls
🇺🇸Oconto Falls, Wisconsin, United States
Lancaster General Hospital
🇺🇸Lancaster, Pennsylvania, United States