46
Participants
Start Date
July 31, 2003
Primary Completion Date
December 31, 2010
Study Completion Date
December 31, 2010
cisplatin
During induction:50 mg/m2,IV on Days 1, 8, 29 \& 36. In any appropriate vehicle over 60 minutes
docetaxel
During consolidation: 75 mg/m2 IV on Day 1, every 21 days for 3 cycles over 60 minutes
etoposide
During induction: 50 mg/m2, IV on Days 1 - 5 Days 29 - 33. In 250 ml of NS over 60 minutes.
conventional surgery
If, based upon the evaluation in Section 7.4a, there is no evidence of progression (see Section 10.2d for definition), patients will proceed to the next appropriate step: Registration #2 and surgery followed by Registration #3 and additional chemotherapy (Sections 7.5 and 7.6). Response determinations (CR,PR, SD) will be required. If criteria for progressive measurable or nonmeasurable disease (see Section 10.0) are met, the patient will then be removed from protocol treatment and receive follow-up according to the schedule. Surgery will be performed 3 - 7 weeks after completion of chemoradiotherapy.
radiation therapy
Radiotherapy is to begin within 24 hours following the start of chemotherapy. Day 1 of radiotherapy must be a Monday, Tuesday or Wednesday, but no later in the week to insure simultaneous therapy for the majority of each chemotherapy cycle. The total dose to the prescription point will be 4,500 cGy given in 25 fractions. The patient will be treated with one fraction per day with all fields treated per day. 180 cGy will be delivered to the isocenter.
Fredericksburg Oncology, Incorporated, Fredericksburg
University of Virginia Cancer Center, Charlottesville
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital, Parkersburg
Wayne Memorial Hospital, Incorporated, Goldsboro
Rutherford Hospital, Rutherfordton
Kinston Medical Specialists, Kinston
CCOP - Upstate Carolina, Spartanburg
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg
AnMed Cancer Center, Anderson
Mayo Clinic - Jacksonville, Jacksonville
University of Mississippi Cancer Clinic, Jackson
Wood County Oncology Center, Bowling Green
Fremont Memorial Hospital, Fremont
Northwest Ohio Oncology Center, Maumee
St. Luke's Hospital, Maumee
Flower Hospital Cancer Center, Sylvania
Fulton County Health Center, Wauseon
Toledo Hospital, Toledo
St. Vincent Mercy Medical Center, Toledo
Medical University of Ohio Cancer Center, Toledo
St. Charles Mercy Hospital, Oregon
Toledo Clinic - Oregon, Oregon
CCOP - Toledo Community Hospital, Toledo
Toledo Clinic, Incorporated - Main Clinic, Toledo
Firelands Regional Medical Center, Sandusky
North Coast Cancer Care, Incorporated, Sandusky
Mercy Hospital of Tiffin, Tiffin
Charles M. Barrett Cancer Center at University Hospital, Cincinnati
St. Rita's Medical Center, Lima
Lima Memorial Hospital, Lima
Saint Anthony Memorial Health Centers, Michigan City
Providence Cancer Institute at Providence Hospital - Southfield Campus, Southfield
St. John Macomb Hospital, Warren
CCOP - Michigan Cancer Research Consortium, Ann Arbor
Haematology-Oncology Associates of Ohio and Michigan, PC, Lambertville
Community Cancer Center of Monroe, Monroe
Mercy Memorial Hospital - Monroe, Monroe
Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods
Genesys Hurley Cancer Institute, Flint
Hurley Medical Center, Flint
Seton Cancer Institute at Saint Mary's - Saginaw, Saginaw
Borgess Medical Center, Kalamazoo
Bronson Methodist Hospital, Kalamazoo
Battle Creek Health System Cancer Care Center, Battle Creek
Foote Memorial Hospital, Jackson
Hickman Cancer Center at Bixby Medical Center, Adrian
Mecosta County Medical Center, Big Rapids
Holland Community Hospital, Holland
Hackley Hospital, Muskegon
Butterworth Hospital at Spectrum Health, Grand Rapids
CCOP - Grand Rapids, Grand Rapids
Lacks Cancer Center at Saint Mary's Health Care, Grand Rapids
Metro Health Hospital, Grand Rapids
Munson Medical Center, Traverse City
CCOP - Duluth, Duluth
Miller - Dwan Medical Center, Duluth
Mayo Clinic Cancer Center, Rochester
Willmar Cancer Center at Rice Memorial Hospital, Willmar
Bismarck Cancer Center, Bismarck
Medcenter One Hospital Cancer Care Center, Bismarck
Mid Dakota Clinic, PC, Bismarck
St. Alexius Medical Center Cancer Center, Bismarck
CCOP - Montana Cancer Consortium, Billings
Hematology-Oncology Centers of the Northern Rockies - Billings, Billings
Northern Rockies Radiation Oncology Center, Billings
St. Vincent Healthcare Cancer Care Services, Billings
Great Falls Clinic - Main Facility, Great Falls
Sletten Cancer Institute at Benefis Healthcare, Great Falls
Great Falls
St. Peter's Hospital, Helena
St. James Healthcare Cancer Care, Butte
Bozeman Deaconess Cancer Center, Bozeman
Community Medical Center, Missoula
Guardian Oncology and Center for Wellness, Missoula
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula
Glacier Oncology, PLLC, Kalispell
Kalispell Medical Oncology at KRMC, Kalispell
Kalispell Regional Medical Center, Kalispell
Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood
Joliet Oncology-Hematology Associates, Limited - West, Joliet
Rush-Copley Cancer Care Center, Aurora
Carle Cancer Center at Carle Foundation Hospital, Urbana
CCOP - Carle Cancer Center, Urbana
Missouri Baptist Cancer Center, St Louis
Arch Medical Services, Incorporated at Center for Cancer Care and Research, St Louis
Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia
Cancer Center of Kansas, PA - Chanute, Chanute
Cancer Center of Kansas, PA - El Dorado, El Dorado
Cancer Center of Kansas, PA - Salina, Salina
Cancer Center of Kansas, PA - Kingman, Kingman
Cancer Center of Kansas, PA - Newton, Newton
Cancer Center of Kansas, PA - Pratt, Pratt
Cancer Center of Kansas, PA - Wellington, Wellington
Cancer Center of Kansas, PA - Winfield, Winfield
Associates in Womens Health, PA - North Review, Wichita
Cancer Center of Kansas, PA - Medical Arts Tower, Wichita
Cancer Center of Kansas, PA - Wichita, Wichita
CCOP - Wichita, Wichita
Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita
Wesley Medical Center, Wichita
Cancer Center of Kansas, PA - Parsons, Parsons
Cancer Center of Kansas, PA - Dodge City, Dodge City
Southwest Medical Center, Liberal
Poudre Valley Hospital, Fort Collins
Welch Cancer Center at Sheridan Memorial Hospital, Sheridan
American Fork Hospital, American Fork
LDS Hospital, Salt Lake City
Utah Cancer Specialists at UCS Cancer Center, Salt Lake City
Cottonwood Hospital Medical Center, Murray
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center, Murray
Logan Regional Hospital, Logan
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center, Ogden
Utah Valley Regional Medical Center - Provo, Provo
Sandra L. Maxwell Cancer Center, Cedar City
Dixie Regional Medical Center - East Campus, St. George
Northwest Cancer Specialists at Rose Quarter Cancer Center, Portland
Auburn Regional Center for Cancer Care, Auburn
St. Francis Hospital, Federal Way
Fred Hutchinson Cancer Research Center, Seattle
Harborview Medical Center, Seattle
Minor and James Medical, PLLC, Seattle
Group Health Central Hospital, Seattle
Polyclinic First Hill, Seattle
St. Joseph Cancer Center, Bellingham
Olympic Hematology and Oncology, Bremerton
Good Samaritan Cancer Center, Puyallup
Allenmore Hospital, Tacoma
CCOP - Northwest, Tacoma
MultiCare Regional Cancer Center at Tacoma General Hospital, Tacoma
St. Clare Hospital, Tacoma
Northwest Cancer Specialists at Vancouver Cancer Center, Vancouver
Cancer Care Northwest - Spokane South, Spokane
Columbia Basin Hematology, Kennewick
Mobile Infirmary Medical Center, Mobile
Regional Cancer Center at Memorial Medical Center, Springfield
Holden Comprehensive Cancer Center at University of Iowa, Iowa City
Saint Joseph Mercy Cancer Center, Ann Arbor
Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn
West Michigan Cancer Center, Kalamazoo
Sparrow Regional Cancer Center, Lansing
Duluth Clinic Cancer Center - Duluth, Duluth
Billings Clinic - Downtown, Billings
Big Sky Oncology, Great Falls
Montana Cancer Specialists at Montana Cancer Center, Missoula
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center, Columbus
MBCCOP - Meharry Medical College - Nashville, Nashville
Providence Centralia Hospital, Centralia
Providence St. Peter Hospital Regional Cancer Center, Olympia
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus, Seattle
University Cancer Center at University of Washington Medical Center, Seattle
Franciscan Cancer Center at St. Joseph Medical Center, Tacoma
Wenatchee Valley Medical Center, Wenatchee
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison
Collaborators (1)
National Cancer Institute (NCI)
NIH
Eastern Cooperative Oncology Group
NETWORK
American College of Surgeons
OTHER
North Central Cancer Treatment Group
NETWORK
NCIC Clinical Trials Group
NETWORK
Cancer and Leukemia Group B
NETWORK
SWOG Cancer Research Network
NETWORK