A Phase III Trial for Locally Recurrent, Previously Irradiated Head and Neck Cancer: Concurrent Re-Irradiation and Chemotherapy Versus Chemotherapy Alone
OBJECTIVES:
Primary
- Compare overall survival of patients with previously irradiated unresectable locally
recurrent squamous cell carcinoma of the head and neck treated with radiotherapy,
cisplatin, and paclitaxel vs cisplatin-based chemotherapy alone.
Secondary
- Compare progression-free survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare quality of life, functional/performance status, and quality-adjusted survival
of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms.
- Arm I: Patients undergo radiotherapy twice daily and receive paclitaxel IV over 1 hour
and cisplatin IV over 30 minutes once daily on days 1-5, 15-19, 29-33, and 43-47.
Patients also receive filgrastim (G-CSF) subcutaneously once daily on days 6-13, 20-27,
34-41, and 48-55.
- Arm II: Patients receive 1 of the following cisplatin-based* regimens at the discretion
of the treating physician:
- Regimen 1: Patients receive cisplatin* IV over 1-2 hours on day 1 and fluorouracil
IV continuously over 96 hours on days 1-4.
- Regimen 2: Patients receive cisplatin* IV over 1-2 hours and paclitaxel IV over 3
hours on day 1.
- Regimen 3: Patients receive cisplatin* IV over 1-2 hours and docetaxel IV over 1
hour on day 1.
NOTE: *Carboplatin may be substituted for cisplatin in patients with creatinine clearance <
50 mL/min or in patients who experience grade 2 or 3 neurotoxicity.
For all regimens, treatment repeats every 21 days for at least 6 courses in the absence of
disease progression or unacceptable toxicity. Patients achieving complete response (CR)
receive 2 additional courses beyond documentation of CR.
Quality of life is assessed at baseline and then at 3, 6, 12, 24, and 36 months.
After completion of study treatment, patients are followed every 3 months for 2 years, every
6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 240 patients (120 per treatment arm) will be accrued for this
study within 5½ years.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Survival
Date of death or last follow-up
No
Stuart J. Wong, MD
Principal Investigator
Medical College of Wisconsin
United States: Federal Government
CDR0000429480
NCT00113399
April 2005
Name | Location |
---|---|
Akron City Hospital | Akron, Ohio 44304 |
Roswell Park Cancer Institute | Buffalo, New York 14263 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
CCOP - North Shore University Hospital | Manhasset, New York 11030 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
Joliet Oncology-Hematology Associates, Limited - West | Joliet, Illinois 60435 |
Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
Medical X-Ray Center, PC | Sioux Falls, South Dakota 57105 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
CCOP - Dayton | Kettering, Ohio 45429 |
Albert Einstein Cancer Center | Philadelphia, Pennsylvania 19141 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
University of Miami Sylvester Comprehensive Cancer Center | Miami, Florida 33136 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center | Milwaukee, Wisconsin 53201-2901 |
University of California Davis Cancer Center | Sacramento, California 95817 |
Mobile Infirmary Medical Center | Mobile, Alabama 36640-0460 |
St. Vincent Mercy Medical Center | Toledo, Ohio 43608 |
McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls, South Dakota 57117-5134 |
CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
Mercy Fitzgerald Hospital | Darby, Pennsylvania 19023 |
Latter Day Saints Hospital | Salt Lake City, Utah 84143 |
Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
Breslin Cancer Center at Ingham Regional Medical Center | Lansing, Michigan 48910 |
Medical University of Ohio Cancer Center | Toledo, Ohio 43614 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
Mary Babb Randolph Cancer Center at West Virginia University Hospitals | Morgantown, West Virginia 26506 |
Saint Anthony's Hospital at Saint Anthony's Health Center | Alton, Illinois 62002 |
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | Gape Girardeau, Missouri 63701 |
David C. Pratt Cancer Center at St. John's Mercy | St. Louis, Missouri 63141 |
Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
Deaconess Billings Clinic - Downtown | Billings, Montana 59101 |
Cottonwood Hospital Medical Center | Murray, Utah 84107 |
McKay-Dee Hospital Center | Ogden, Utah 84403 |
Utah Cancer Specialists at UCS Cancer Center | Salt Lake City, Utah 84106 |
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | Saint Joseph, Michigan 49085 |
Lenoir Memorial Cancer Center | Kinston, North Carolina 28503-1678 |
MBCCOP - Medical College of Georgia Cancer Center | Augusta, Georgia 30912-3730 |
CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
Don Monti Comprehensive Cancer Center at North Shore University Hospital | Manhasset, New York 11030 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton, New Jersey 08053 |
Fox Chase Virtua Health Cancer Program at Virtua West Jersey | Voorhees, New Jersey 08043 |
Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
All Saints Cancer Center at Wheaton Franciscan Healthcare | Racine, Wisconsin 53405 |
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale, Florida 33308 |
Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter, Florida 33458 |
St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove, Indiana 46107 |
Howard Community Hospital at Howard Regional Health System | Kokomo, Indiana 46904 |
Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
Reid Hospital & Health Care Services, Incorporated | Richmond, Indiana 47374 |
Feist-Weiller Cancer Center at Louisiana State University Health Sciences | Shreveport, Louisiana 71130-3932 |
Hickman Cancer Center at Bixby Medical Center | Adrian, Michigan 49221 |
Saint Francis Medical Center | Cape Girardeau, Missouri 63701 |
Kingsbury Center for Cancer Care at Cheshire Medical Center | Keene, New Hampshire 03431 |
Cancer Care Center at Medcenter One Hospital | Bismarck, North Dakota 58501 |
Bismarck Cancer Center | Bismarck, North Dakota 58501 |
St. Alexius Medical Center | Bismarck, North Dakota 58502 |
Grandview Hospital | Dayton, Ohio 45405 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
Good Samaritan Hospital | Dayton, Ohio 45406 |
Blanchard Valley Medical Associates | Findlay, Ohio 45840 |
Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
Lima Memorial Hospital | Lima, Ohio 45804 |
Northwest Ohio Oncology Center | Maumee, Ohio 43537 |
Middletown Regional Hospital | Middletown, Ohio 45044 |
St. Charles Mercy Hospital | Oregon, Ohio 43616 |
Firelands Regional Medical Center | Sandusky, Ohio 44870 |
Toledo Clinic, Incorporated - Main Clinic | Toledo, Ohio 43623 |
UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
Dixie Regional Medical Center - East Campus | Saint George, Utah 84770 |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa, Florida 33612 |
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford | Salem, Ohio 44460 |
Cancer Treatment Center | Wooster, Ohio 44691 |
Allegheny Cancer Center at Allegheny General Hospital | Pittsburgh, Pennsylvania 15212 |
West Allis Memorial Hospital | West Allis, Wisconsin 53227 |
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler | Savannah, Georgia 31405 |
Flower Hospital Cancer Center | Sylvania, Ohio 43560 |
Methodist Cancer Center at Methodist Hospital - Omaha | Omaha, Nebraska 68114 |
Mid Dakota Clinic, PC | Bismarck, North Dakota 58501 |
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center | Pomona, California 91767 |
Radiological Associates of Sacramento Medical Group, Incorporated | Sacramento, California 95815 |
St. John's Cancer Center at St. John's Medical Center | Anderson, Indiana 46016 |
Long Island College Hospital | Brooklyn, New York 11201 |
Rutherford Hospital | Rutherfordton, North Carolina 28139 |
AnMed Health Cancer Center | Anderson, South Carolina 29621 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Community Memorial Hospital Cancer Care Center | Menomonee Falls, Wisconsin 53051 |
Cancer Institute at St. John's Hospital | Springfield, Illinois 62701 |
University of Wisconcin Cancer Center at Aspirus Wausau Hospital | Wausau, Wisconsin 54401 |
Solano Radiation Oncology Center | Vacaville, California 95687 |
Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center | Boca Raton, Florida 33486 |
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare | Vineland, New Jersey 08360 |
Mercy General Hospital | Sacramento, California 95819 |
United States Air Force Medical Center - Wright-Patterson | Wright-Patterson AFB, Ohio 45433-5529 |
Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields | Olympia Fields, Illinois 60461 |
J. Phillip Citta Regional Cancer Center at Community Medical Center | Toms River, New Jersey 08755 |
St. Joseph's Mercy Cancer Center | Hot Springs, Arkansas 71913 |
MaineGeneral Medical Center - Waterville Campus | Waterville, Maine 04901 |
Auburn Radiation Oncology | Auburn, California 95603 |
Radiation Oncology Centers - Cameron Park | Cameron Park, California 95682 |
Radiation Oncology Center - Roseville | Roseville, California 95661 |
Mercy Cancer Center at Mercy San Juan Medical Center | Carmichael, California 95608 |
Norris Cotton Cancer Center - North | Saint Johnsbury, Vermont 05819 |
Alle-Kiski Medical Center | Natrona Heights, Pennsylvania 15065 |