Cisplatin and Docetaxel With or Without Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Newly Diagnosed Stage III Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Interventions
- Biological: filgrastimBiological: pegfilgrastimProcedure: adjuvant therapyProcedure: conventional surgeryProcedure: neoadjuvant therapyRadiation: radiation therapy
- Registration Number
- NCT00113386
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Cisplatin and docetaxel may make tumor cells more sensitive to radiation therapy. Giving more than one drug (combination chemotherapy) together with radiation therapy before surgery may shrink the tumor so it can be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving cisplatin and docetaxel together with radiation therapy is more effective than giving cisplatin together with docetaxel in treating non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying cisplatin, docetaxel, and radiation therapy to see how well they work compared to cisplatin and docetaxel in treating patients who are undergoing surgery for newly diagnosed stage III non-small cell lung cancer.
- Detailed Description
OBJECTIVES:
Primary
* Compare overall survival of patients with newly diagnosed favorable prognosis stage IIIA non-small cell lung cancer treated with neoadjuvant cisplatin and docetaxel with vs without thoracic conformal radiotherapy followed by surgical resection and docetaxel.
Secondary
* Compare median and progression-free survival of patients treated with these regimens.
* Compare clinical and pathologic response rates in patients treated with these regimens.
* Compare the toxicity of these regimens in these patients.
* Correlate pathological complete response with disease-free and overall survival of patients treated with these regimens.
* Correlate DNA damage repair genes (ERCC1 and XRCC1), microtubule-related proteins (TUBB-III and MAP4), and shed tumor DNA with response and outcome in patients treated with these regimens.
* Correlate protein profiles, using MALDI-TOF proteomic analysis of tumor and serum, with response and prognosis in patients treated with these regimens.
* Compare quality of life of patients treated with these regimens.
* Determine the efficacy of fludeoxyglucose F 18 positron emission tomography scanning in assessing pathological response of the tumor and the mediastinal lymph nodes and in predicting long-term outcome in patients treated with these regimens.
* Correlate comorbid conditions with survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to T stage (T1 vs T2-3), number of involved mediastinal lymph nodes (1 vs 2 or more vs not evaluable), and nodal micrometastases vs clinically involved nodes (mN2 vs cN2).
* Induction therapy: Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive cisplatin IV over 1 hour and docetaxel IV over 1 hour on days 1 and 22.
* Arm II: Patients undergo thoracic conformal radiotherapy once daily 5 days a week for approximately 5½ weeks (total of 28 doses). Patients also receive cisplatin IV over 1 hour on days 1, 8, 22, and 29 and docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29.
* Surgery: Within 4-8 weeks after completion of induction therapy, patients with stable disease or better undergo a lobectomy or pneumonectomy with a formal systematic mediastinal lymph node dissection.
* Consolidation therapy: Beginning 4-6 weeks after surgery, patients receive docetaxel IV over 1 hour on days 1, 22, and 43 and pegfilgrastim or filgrastim (G-CSF) subcutaneously on days 2, 23, and 44.
Quality of life is assessed at baseline, within 2 weeks after completion of induction therapy, and then at 6 and 12 months after surgery.
After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 574 patients will be accrued for this study within 4 years.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 19
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Induction chemotherapy, surgery, consolidation chemotherapy docetaxel Induction/surgery/consolidation Induction chemotherapy, surgery, consolidation chemotherapy filgrastim Induction/surgery/consolidation Chemotherapy and radiation, surgery, consolidation ch conventional surgery Induction/radiation/surgery/cosolidation Induction chemotherapy, surgery, consolidation chemotherapy pegfilgrastim Induction/surgery/consolidation Induction chemotherapy, surgery, consolidation chemotherapy adjuvant therapy Induction/surgery/consolidation Induction chemotherapy, surgery, consolidation chemotherapy conventional surgery Induction/surgery/consolidation Induction chemotherapy, surgery, consolidation chemotherapy neoadjuvant therapy Induction/surgery/consolidation Chemotherapy and radiation, surgery, consolidation ch filgrastim Induction/radiation/surgery/cosolidation Chemotherapy and radiation, surgery, consolidation ch pegfilgrastim Induction/radiation/surgery/cosolidation Chemotherapy and radiation, surgery, consolidation ch docetaxel Induction/radiation/surgery/cosolidation Chemotherapy and radiation, surgery, consolidation ch adjuvant therapy Induction/radiation/surgery/cosolidation Chemotherapy and radiation, surgery, consolidation ch neoadjuvant therapy Induction/radiation/surgery/cosolidation Chemotherapy and radiation, surgery, consolidation ch radiation therapy Induction/radiation/surgery/cosolidation Chemotherapy and radiation, surgery, consolidation ch cisplatin Induction/radiation/surgery/cosolidation Induction chemotherapy, surgery, consolidation chemotherapy cisplatin Induction/surgery/consolidation
- Primary Outcome Measures
Name Time Method Comparison of Overall Survival Date of death or date of last follow-up
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (76)
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
St. Agnes Hospital Cancer Center
🇺🇸Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Allegheny Cancer Center at Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Albert Einstein Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
CCOP - Virginia Mason Research Center
🇺🇸Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
🇺🇸Seattle, Washington, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Veterans Affairs Medical Center - Portland
🇺🇸Portland, Oregon, United States
Oregon Health & Science University Cancer Institute
🇺🇸Portland, Oregon, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Methodist Cancer Center at Methodist Hospital - Omaha
🇺🇸Omaha, Nebraska, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
🇺🇸Columbus, Ohio, United States
St. John's Regional Medical Center
🇺🇸Joplin, Missouri, United States
Upper Michigan Cancer Center at Marquette General Hospital
🇺🇸Marquette, Michigan, United States
Siteman Cancer Center at Barnes-Jewish Hospital
🇺🇸St Louis, Missouri, United States
Valley Hospital - Ridgewood
🇺🇸Ridgewood, New Jersey, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
Good Samaritan Cancer Center at Good Samaritan Hospital
🇺🇸Kearney, Nebraska, United States
Frederick Memorial Hospital Regional Cancer Therapy Center
🇺🇸Frederick, Maryland, United States
St. John's Regional Health Center
🇺🇸Springfield, Missouri, United States
Lancaster General Hospital
🇺🇸Lancaster, Pennsylvania, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
Madigan Army Medical Center - Tacoma
🇺🇸Tacoma, Washington, United States
Vince Lombardi Cancer Clinic - Sheboygan
🇺🇸Sheboygan, Wisconsin, United States
Community Cancer Center
🇺🇸Normal, Illinois, United States
Leo W. Jenkins Cancer Center at ECU Medical School
🇺🇸Greenville, North Carolina, United States
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
🇺🇸Green Bay, Wisconsin, United States
Faxton Regional Cancer Center
🇺🇸Utica, New York, United States
St. Luke's Hospital Cancer Center
🇺🇸Bethlehem, Pennsylvania, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
🇺🇸Pinehurst, North Carolina, United States
Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Dean Medical Center - Madison
🇺🇸Madison, Wisconsin, United States
York Cancer Center at Apple Hill Medical Center
🇺🇸York, Pennsylvania, United States
Phoebe Cancer Center at Phoebe Putney Memorial Hospital
🇺🇸Albany, Georgia, United States
Cancer Institute at St. John's Hospital
🇺🇸Springfield, Illinois, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Cancer Center at Providence Alaska Medical Center
🇺🇸Anchorage, Alaska, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Cancer Care Center at John Muir Health - Concord Campus
🇺🇸Concord, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Poudre Valley Hospital
🇺🇸Fort Collins, Colorado, United States
Memorial Hospital
🇺🇸Colorado Springs, Colorado, United States
Front Range Cancer Specialists
🇺🇸Fort Collins, Colorado, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
🇺🇸Jupiter, Florida, United States
Watson Clinic, LLC
🇺🇸Lakeland, Florida, United States
Northeast Georgia Medical Center
🇺🇸Gainesville, Georgia, United States
Delnor Community Hospital - Geneva
🇺🇸Geneva, Illinois, United States
Advocate Christ Medical Center
🇺🇸Oak Lawn, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Cancer Treatment Center at Pekin Hospital
🇺🇸Pekin, Illinois, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
🇺🇸Peoria, Illinois, United States
Reid Hospital & Health Care Services, Incorporated
🇺🇸Richmond, Indiana, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
Hematology Oncology Associates of the Quad Cities
🇺🇸Bettendorf, Iowa, United States
Genesis Regional Cancer Center at Genesis Medical Center
🇺🇸Davenport, Iowa, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
🇺🇸Lexington, Kentucky, United States
Lenoir Memorial Cancer Center
🇺🇸Kinston, North Carolina, United States
NYU Cancer Institute at New York University Medical Center
🇺🇸New York, New York, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
U.T. Cancer Institute at University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States