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
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.
Interventional
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
No
Maria Werner-Wasik, MD
Principal Investigator
Kimmel Cancer Center (KCC)
United States: Federal Government
RTOG-0412
NCT00113386
April 2005
Name | Location |
---|---|
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 |