Phase III Randomized Trial of Preoperative Chemotherapy Versus Preoperative Concurrent Chemotherapy and Thoracic Radiotherapy Followed by Surgical Resection and Consolidation Chemotherapy in Favorable Prognosis Patients With Stage IIIA (N2) Non-Small Cell Lung Cancer
- 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
- 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.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Comparison of Overall Survival
Date of death or date of last follow-up
Maria Werner-Wasik, MD
Kimmel Cancer Center (KCC)
United States: Federal Government
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|Mayo Clinic - Jacksonville||Jacksonville, Florida 32224|
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|Cardinal Bernardin Cancer Center at Loyola University Medical Center||Maywood, Illinois 60153-5500|
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|CCOP - Upstate Carolina||Spartanburg, South Carolina 29303|
|Medical City Dallas Hospital||Dallas, Texas 75230|
|CCOP - Atlanta Regional||Atlanta, Georgia 30342-1701|
|CCOP - Christiana Care Health Services||Wilmington, Delaware 19899|
|CCOP - Mount Sinai Medical Center||Miami Beach, Florida 33140|
|CCOP - Michigan Cancer Research Consortium||Ann Arbor, Michigan 48106|
|Bronson Methodist Hospital||Kalamazoo, Michigan 49007|
|Penn State Cancer Institute at Milton S. Hershey Medical Center||Hershey, Pennsylvania 17033-0850|
|Dean Medical Center - Madison||Madison, Wisconsin 53717|
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|
|Memorial Hospital of South Bend||South Bend, Indiana 46601|
|Albert Einstein Cancer Center||Philadelphia, Pennsylvania 19141|
|CCOP - Greenville||Greenville, South Carolina 29615|
|Siteman Cancer Center at Barnes-Jewish Hospital||Saint Louis, Missouri 63110|
|Charles M. Barrett Cancer Center at University Hospital||Cincinnati, Ohio 45267-0526|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University||Columbus, Ohio 43210-1240|
|Kimmel Cancer Center at Thomas Jefferson University - Philadelphia||Philadelphia, Pennsylvania 19107|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|Veterans Affairs Medical Center - Portland||Portland, Oregon 97207|
|CCOP - Virginia Mason Research Center||Seattle, Washington 98101|
|University of California Davis Cancer Center||Sacramento, California 95817|
|Arkansas Cancer Research Center at University of Arkansas for Medical Sciences||Little Rock, Arkansas 72205|
|Markey Cancer Center at University of Kentucky Chandler Medical Center||Lexington, Kentucky 40536-0084|
|Swedish Cancer Institute at Swedish Medical Center - First Hill Campus||Seattle, Washington 98104|
|St. John's Regional Health Center||Springfield, Missouri 65804|
|St. Luke's Hospital Cancer Center||Bethlehem, Pennsylvania 18015|
|Advocate Christ Medical Center||Oak Lawn, Illinois 60453|
|NYU Cancer Institute at New York University Medical Center||New York, New York 10016|
|SUNY Upstate Medical University Hospital||Syracuse, New York 13210|
|Hollings Cancer Center at Medical University of South Carolina||Charleston, South Carolina 29425|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas||Dallas, Texas 75390|
|Hematology Oncology Associates of the Quad Cities||Bettendorf, Iowa 52722|
|UNMC Eppley Cancer Center at the University of Nebraska Medical Center||Omaha, Nebraska 68198-7680|
|Lenoir Memorial Cancer Center||Kinston, North Carolina 28503-1678|
|Madigan Army Medical Center - Tacoma||Tacoma, Washington 98431|
|Front Range Cancer Specialists||Fort Collins, Colorado 80528|
|Moores UCSD Cancer Center||La Jolla, California 92093-0658|
|Memorial Hospital||Colorado Springs, Colorado 80909|
|Poudre Valley Hospital||Fort Collins, Colorado 80524|
|Ella Milbank Foshay Cancer Center at Jupiter Medical Center||Jupiter, Florida 33458|
|Community Cancer Center||Normal, Illinois 61761|
|Cancer Treatment Center at Pekin Hospital||Pekin, Illinois 61554|
|Oncology Hematology Associates of Central Illinois, PC - Peoria||Peoria, Illinois 61615|
|OSF St. Francis Medical Center||Peoria, Illinois 61637|
|Reid Hospital & Health Care Services, Incorporated||Richmond, Indiana 47374|
|Genesis Regional Cancer Center at Genesis Medical Center||Davenport, Iowa 52803|
|Upper Michigan Cancer Center at Marquette General Hospital||Marquette, Michigan 49855|
|Lancaster General Hospital||Lancaster, Pennsylvania 17604-3555|
|Northeast Georgia Medical Center||Gainesville, Georgia 30501|
|Allegheny Cancer Center at Allegheny General Hospital||Pittsburgh, Pennsylvania 15212|
|Leo W. Jenkins Cancer Center at ECU Medical School||Greenville, North Carolina 27834|
|York Cancer Center at Apple Hill Medical Center||York, Pennsylvania 17405|
|Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center||Green Bay, Wisconsin 54311|
|Vince Lombardi Cancer Clinic - Sheboygan||Sheboygan, Wisconsin 53081|
|Methodist Cancer Center at Methodist Hospital - Omaha||Omaha, Nebraska 68114|
|FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center||Pinehurst, North Carolina 28374|
|Oregon Health & Science University Cancer Institute||Portland, Oregon 97239-3098|
|Phoebe Cancer Center at Phoebe Putney Memorial Hospital||Albany, Georgia 31702|
|Good Samaritan Cancer Center at Good Samaritan Hospital||Kearney, Nebraska 68848-1990|
|Cancer Institute at St. John's Hospital||Springfield, Illinois 62701|
|Frederick Memorial Hospital Regional Cancer Therapy Center||Frederick, Maryland 21701|
|St. John's Regional Medical Center||Joplin, Missouri 64804|
|U.T. Cancer Institute at University of Tennessee Medical Center||Knoxville, Tennessee 37920-2911|
|Valley Hospital - Ridgewood||Ridgewood, New Jersey 07450|
|Faxton Regional Cancer Center||Utica, New York 13502|
|Watson Clinic, LLC||Lakeland, Florida 33804-5000|
|Cancer Care Center at John Muir Health - Concord Campus||Concord, California 94524-4110|
|Cancer Center at Providence Alaska Medical Center||Anchorage, Alaska 99519-6604|
|Delnor Community Hospital - Geneva||Geneva, Illinois 60134|
|St. Agnes Hospital Cancer Center||Baltimore, Maryland 21229|