- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00113399
Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer That Cannot Be Removed By Surgery
A Phase III Trial for Locally Recurrent, Previously Irradiated Head and Neck Cancer: Concurrent Re-Irradiation and Chemotherapy Versus Chemotherapy Alone
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cisplatin and paclitaxel may make tumor cells more sensitive to radiation therapy. Giving more than one drug (combination chemotherapy) and giving them with radiation therapy may kill more tumor cells. It is not yet known whether giving radiation therapy together with combination chemotherapy is more effective than giving combination chemotherapy alone in treating head and neck cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating patients with recurrent head and neck cancer that cannot be removed by surgery.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 3
Kontakte und Standorte
Studienorte
-
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Alabama
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Birmingham, Alabama, Vereinigte Staaten, 35294
- University of Alabama at Birmingham Comprehensive Cancer Center
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Mobile, Alabama, Vereinigte Staaten, 36652-2144
- Mobile Infirmary Medical Center
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Arkansas
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Hot Springs, Arkansas, Vereinigte Staaten, 71913
- St. Joseph's Mercy Cancer Center
-
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California
-
Auburn, California, Vereinigte Staaten, 95603
- Auburn Radiation Oncology
-
Cameron Park, California, Vereinigte Staaten, 95682
- Radiation Oncology Centers - Cameron Park
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Carmichael, California, Vereinigte Staaten, 95608
- Mercy Cancer Center at Mercy San Juan Medical Center
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Pomona, California, Vereinigte Staaten, 91767
- Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
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Roseville, California, Vereinigte Staaten, 95661
- Radiation Oncology Center - Roseville
-
Sacramento, California, Vereinigte Staaten, 95815
- Radiological Associates of Sacramento Medical Group, Incorporated
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Sacramento, California, Vereinigte Staaten, 95819
- Mercy General Hospital
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Sacramento, California, Vereinigte Staaten, 95817
- University of California Davis Cancer Center
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Vacaville, California, Vereinigte Staaten, 95687
- Solano Radiation Oncology Center
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Florida
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Boca Raton, Florida, Vereinigte Staaten, 33486
- Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center
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Fort Lauderdale, Florida, Vereinigte Staaten, 33308
- Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
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Gainesville, Florida, Vereinigte Staaten, 32610-0232
- University of Florida Shands Cancer Center
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Jupiter, Florida, Vereinigte Staaten, 33458
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
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Miami, Florida, Vereinigte Staaten, 33136
- University of Miami Sylvester Comprehensive Cancer Center
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Miami Beach, Florida, Vereinigte Staaten, 33140
- CCOP - Mount Sinai Medical Center
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Tampa, Florida, Vereinigte Staaten, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
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Georgia
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Augusta, Georgia, Vereinigte Staaten, 30912
- MBCCOP - Medical College of Georgia Cancer Center
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Savannah, Georgia, Vereinigte Staaten, 31405
- Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
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Illinois
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Alton, Illinois, Vereinigte Staaten, 62002
- Saint Anthony's Hospital at Saint Anthony's Health Center
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Aurora, Illinois, Vereinigte Staaten, 60507
- Rush-Copley Cancer Care Center
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Joliet, Illinois, Vereinigte Staaten, 60435
- Joliet Oncology-Hematology Associates, Limited - West
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Olympia Fields, Illinois, Vereinigte Staaten, 60461
- Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
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Springfield, Illinois, Vereinigte Staaten, 62702
- Cancer Institute at St. John's Hospital
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Urbana, Illinois, Vereinigte Staaten, 61801
- Carle Cancer Center at Carle Foundation Hospital
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Urbana, Illinois, Vereinigte Staaten, 61801
- CCOP - Carle Cancer Center
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Indiana
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Anderson, Indiana, Vereinigte Staaten, 46016
- St. John's Cancer Center at St. John's Medical Center
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Beech Grove, Indiana, Vereinigte Staaten, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
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Elkhart, Indiana, Vereinigte Staaten, 46515
- Elkhart General Hospital
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Indianapolis, Indiana, Vereinigte Staaten, 46202-5289
- Indiana University Cancer Center
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Kokomo, Indiana, Vereinigte Staaten, 46904
- Howard Community Hospital at Howard Regional Health System
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La Porte, Indiana, Vereinigte Staaten, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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Michigan City, Indiana, Vereinigte Staaten, 46360
- Saint Anthony Memorial Health Centers
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Richmond, Indiana, Vereinigte Staaten, 47374
- Reid Hospital & Health Care Services, Incorporated
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South Bend, Indiana, Vereinigte Staaten, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, Vereinigte Staaten, 46601
- CCOP - Northern Indiana CR Consortium
-
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Louisiana
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Shreveport, Louisiana, Vereinigte Staaten, 71130-3932
- Feist-Weiller Cancer Center at Louisiana State University Health Sciences
-
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Maine
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Waterville, Maine, Vereinigte Staaten, 04901
- MaineGeneral Medical Center - Waterville Campus
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Maryland
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Baltimore, Maryland, Vereinigte Staaten, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Michigan
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Adrian, Michigan, Vereinigte Staaten, 49221
- Hickman Cancer Center at Bixby Medical Center
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Ann Arbor, Michigan, Vereinigte Staaten, 48109-0942
- University of Michigan Comprehensive Cancer Center
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Detroit, Michigan, Vereinigte Staaten, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Lansing, Michigan, Vereinigte Staaten, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
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St. Joseph, Michigan, Vereinigte Staaten, 49085
- Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
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Missouri
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Cape Girardeau, Missouri, Vereinigte Staaten, 63701
- Saint Francis Medical Center
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Gape Girardeau, Missouri, Vereinigte Staaten, 63701
- Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
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Saint Louis, Missouri, Vereinigte Staaten, 63141
- David C. Pratt Cancer Center at St. John's Mercy
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St Louis, Missouri, Vereinigte Staaten, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital
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St. Louis, Missouri, Vereinigte Staaten, 63141
- CCOP - St. Louis-Cape Girardeau
-
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Montana
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Billings, Montana, Vereinigte Staaten, 59101
- CCOP - Montana Cancer Consortium
-
Billings, Montana, Vereinigte Staaten, 59101
- Northern Rockies Radiation Oncology Center
-
Billings, Montana, Vereinigte Staaten, 59107-7000
- Deaconess Billings Clinic - Downtown
-
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Nebraska
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Omaha, Nebraska, Vereinigte Staaten, 68114
- Methodist Cancer Center at Methodist Hospital - Omaha
-
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Nevada
-
Las Vegas, Nevada, Vereinigte Staaten, 89106
- CCOP - Nevada Cancer Research Foundation
-
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New Hampshire
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Keene, New Hampshire, Vereinigte Staaten, 03431
- Kingsbury Center for Cancer Care at Cheshire Medical Center
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Lebanon, New Hampshire, Vereinigte Staaten, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Marlton, New Jersey, Vereinigte Staaten, 08053
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
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Toms River, New Jersey, Vereinigte Staaten, 08755
- J. Phillip Citta Regional Cancer Center at Community Medical Center
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Vineland, New Jersey, Vereinigte Staaten, 08360
- Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
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Voorhees, New Jersey, Vereinigte Staaten, 08043
- Fox Chase Virtua Health Cancer Program at Virtua West Jersey
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New York
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Brooklyn, New York, Vereinigte Staaten, 11201
- Long Island College Hospital
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Buffalo, New York, Vereinigte Staaten, 14263-0001
- Roswell Park Cancer Institute
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Manhasset, New York, Vereinigte Staaten, 11030
- CCOP - North Shore University Hospital
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Manhasset, New York, Vereinigte Staaten, 11030
- Don Monti Comprehensive Cancer Center at North Shore University Hospital
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New Hyde Park, New York, Vereinigte Staaten, 11042
- Long Island Jewish Medical Center
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North Carolina
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Kinston, North Carolina, Vereinigte Staaten, 28501
- Lenoir Memorial Cancer Center
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Rutherfordton, North Carolina, Vereinigte Staaten, 28139
- Rutherford Hospital
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North Dakota
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Bismarck, North Dakota, Vereinigte Staaten, 58501
- Bismarck Cancer Center
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Bismarck, North Dakota, Vereinigte Staaten, 58501
- Mid Dakota Clinic, PC
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Bismarck, North Dakota, Vereinigte Staaten, 58501
- Cancer Care Center at Medcenter One Hospital
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Bismarck, North Dakota, Vereinigte Staaten, 58502
- St. Alexius Medical Center
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Ohio
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Akron, Ohio, Vereinigte Staaten, 44307
- McDowell Cancer Center at Akron General Medical Center
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Akron, Ohio, Vereinigte Staaten, 44309-2090
- Akron City Hospital
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Dayton, Ohio, Vereinigte Staaten, 45428
- Veterans Affairs Medical Center - Dayton
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Dayton, Ohio, Vereinigte Staaten, 45405
- Grandview Hospital
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Dayton, Ohio, Vereinigte Staaten, 45406
- Good Samaritan Hospital
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Dayton, Ohio, Vereinigte Staaten, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
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Dayton, Ohio, Vereinigte Staaten, 45429
- CCOP - Dayton
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Findlay, Ohio, Vereinigte Staaten, 45840
- Blanchard Valley Medical Associates
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Kettering, Ohio, Vereinigte Staaten, 45429
- Charles F. Kettering Memorial Hospital
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Lima, Ohio, Vereinigte Staaten, 45804
- Lima Memorial Hospital
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Maumee, Ohio, Vereinigte Staaten, 43623
- Northwest Ohio Oncology Center
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Middletown, Ohio, Vereinigte Staaten, 45044
- Middletown Regional Hospital
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Oregon, Ohio, Vereinigte Staaten, 43616
- St. Charles Mercy Hospital
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Salem, Ohio, Vereinigte Staaten, 44460
- Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
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Sandusky, Ohio, Vereinigte Staaten, 44870
- Firelands Regional Medical Center
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Sylvania, Ohio, Vereinigte Staaten, 43560
- Flower Hospital Cancer Center
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Toledo, Ohio, Vereinigte Staaten, 43608
- St. Vincent Mercy Medical Center
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Toledo, Ohio, Vereinigte Staaten, 43614
- Medical University of Ohio Cancer Center
-
Toledo, Ohio, Vereinigte Staaten, 43617
- CCOP - Toledo Community Hospital
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Toledo, Ohio, Vereinigte Staaten, 43623
- Toledo Clinic, Incorporated - Main Clinic
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Troy, Ohio, Vereinigte Staaten, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
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Wooster, Ohio, Vereinigte Staaten, 44691
- Cancer Treatment Center
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Wright-Patterson Afb, Ohio, Vereinigte Staaten, 45433-5529
- United States Air Force Medical Center - Wright-Patterson
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Xenia, Ohio, Vereinigte Staaten, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
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Pennsylvania
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Darby, Pennsylvania, Vereinigte Staaten, 19023
- Mercy Fitzgerald Hospital
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Natrona Heights, Pennsylvania, Vereinigte Staaten, 15065
- Alle-Kiski Medical Center
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19111-2497
- Fox Chase Cancer Center - Philadelphia
-
Philadelphia, Pennsylvania, Vereinigte Staaten, 19141
- Albert Einstein Cancer Center
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19107-5541
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
-
Pittsburgh, Pennsylvania, Vereinigte Staaten, 15212
- Allegheny Cancer Center at Allegheny General Hospital
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South Carolina
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Anderson, South Carolina, Vereinigte Staaten, 29621
- AnMed Health Cancer Center
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Charleston, South Carolina, Vereinigte Staaten, 29425
- Hollings Cancer Center at Medical University of South Carolina
-
Spartanburg, South Carolina, Vereinigte Staaten, 29303
- CCOP - Upstate Carolina
-
Spartanburg, South Carolina, Vereinigte Staaten, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
-
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South Dakota
-
Rapid City, South Dakota, Vereinigte Staaten, 57701
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, Vereinigte Staaten, 57117-5039
- Sioux Valley Hospital and University of South Dakota Medical Center
-
Sioux Falls, South Dakota, Vereinigte Staaten, 57105
- Medical X-Ray Center, PC
-
-
Utah
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Murray, Utah, Vereinigte Staaten, 84107
- Cottonwood Hospital Medical Center
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Ogden, Utah, Vereinigte Staaten, 84403
- McKay-Dee Hospital Center
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Provo, Utah, Vereinigte Staaten, 84604
- Utah Valley Regional Medical Center - Provo
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Saint George, Utah, Vereinigte Staaten, 84770
- Dixie Regional Medical Center - East Campus
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Salt Lake City, Utah, Vereinigte Staaten, 84106
- Utah Cancer Specialists at UCS Cancer Center
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Salt Lake City, Utah, Vereinigte Staaten, 84143
- Latter Day Saints Hospital
-
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Vermont
-
Saint Johnsbury, Vermont, Vereinigte Staaten, 05819
- Norris Cotton Cancer Center - North
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West Virginia
-
Morgantown, West Virginia, Vereinigte Staaten, 26506
- Mary Babb Randolph Cancer Center at West Virginia University Hospitals
-
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Wisconsin
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Madison, Wisconsin, Vereinigte Staaten, 53792-6164
- University of Wisconsin Comprehensive Cancer Center
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Menomonee Falls, Wisconsin, Vereinigte Staaten, 53051
- Community Memorial Hospital Cancer Care Center
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Milwaukee, Wisconsin, Vereinigte Staaten, 53226
- Medical College of Wisconsin Cancer Center
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Milwaukee, Wisconsin, Vereinigte Staaten, 53215
- Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
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Racine, Wisconsin, Vereinigte Staaten, 53405
- All Saints Cancer Center at Wheaton Franciscan Healthcare
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Wausau, Wisconsin, Vereinigte Staaten, 54401
- University of Wisconcin Cancer Center at Aspirus Wausau Hospital
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West Milwaukee, Wisconsin, Vereinigte Staaten, 53227
- West Allis Memorial Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
DISEASE CHARACTERISTICS:
Histologically* or cytologically* confirmed squamous cell carcinoma (SCC) of the oral cavity, oropharynx, hypopharynx, or larynx, including any of the following histologic variants:
- Spindle cell carcinoma
- Poorly differentiated keratin-positive carcinoma
- Lymphoepithelioma NOTE: *Biopsy or primary tumor and/or fine needle aspiration of the metastatic lymph node required
Original or second primary tumor
- Recurrent neck metastases with unknown primary allowed
- Locally recurrent disease
- Measurable disease
Unresectable disease
- Attempted surgical resection allowed provided surgery was performed ≥ 3 months ago, wound is completely healed, and there is no sign of carotid exposure
Must have had prior radiotherapy for SCC of the head and neck with > 75% of the present tumor volume in areas irradiated at doses ≥ 45 Gy but ≤ 75 Gy
- Able to successfully re-irradiate the area of the gross tumor volume without exceeding lifetime spinal cord dose of 54 Gy as determined by physical examination and CT scan and/or MRI performed within the past 8 weeks
First recurrence occurred > 6 months after completion of radiotherapy
- More than 1 recurrence allowed provided the above criteria for first recurrence has been met
- No primary tumor of the nasopharynx or salivary gland
No distant metastases by history or physical examination, chest CT scan, and CT scan or MRI of the tumor site
- Patients with equivocal pulmonary nodules are eligible provided the nodules are < 1 cm, can be safely biopsied, or are negative by positron emission tomography imaging
- No circumferential tumor involvement of the carotid sheath by imaging unless prophylactic carotid stent is placed
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,800/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)
Hepatic
- AST or ALT < 2 times upper limit of normal (ULN)
- Bilirubin < 1.5 mg/dL
- No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
Renal
- Creatinine clearance > 50 mL/min
- Calcium < 11.5 mg/dL
Cardiovascular
- No New York Heart Association class III or IV heart disease
- No other symptomatic or uncontrolled cardiac disease
Pulmonary
- No chronic obstructive pulmonary disease exacerbation
- No other respiratory illness requiring hospitalization within the past 6 months or that would preclude study therapy
Immunologic
- No AIDS
- No prior allergic reaction to E. coli-derived products
- No acute bacterial or fungal infection requiring IV antibiotics
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 30 days after completion of study treatment
- No other invasive malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the breast, oral cavity, or cervix
- No pre-existing peripheral sensory neuropathy > grade 2
- No other severe active co-morbidity
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- At least 6 months since prior chemotherapy
No prior systemic chemotherapy for recurrent SCC of the head and neck
- Prior neoadjuvant, adjuvant, and/or concurrent chemotherapy and radiotherapy for initial SCC of the head and neck allowed
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- See Chemotherapy
- At least 6 months since prior radiotherapy
Surgery
- See Disease Characteristics
Other
- Prior cyclooxygenase-2 inhibitor or retinoids for chemoprevention allowed
- At least 6 months since prior epidermal growth factor receptor (EGFR) inhibitors or other targeted agents
- No prior EGFR inhibitors or other targeted agents for recurrent SCC of the head and neck
- No concurrent cimetidine or allopurinol (for patients on arm II, regimen 1)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Sonstiges: Radiotherapy and chemotherapy
Radiotherapy/paclitaxel/cisplatin/filgrastim
|
|
Sonstiges: Chemotherapy
Cisplatin/fluorouracil/paclitaxel/docetaxel
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Overall Survival
Zeitfenster: Date of death or last follow-up
|
Date of death or last follow-up
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Stuart J. Wong, MD, Medical College Of Wisconsin
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
- rezidivierendes metastasierendes Plattenepithelkarzinom mit okkultem Primärtumor
- rezidivierendes Plattenepithelkarzinom der Lippen- und Mundhöhle
- rezidivierendes Plattenepithelkarzinom des Oropharynx
- rezidivierendes Lymphoepitheliom des Oropharynx
- rezidivierendes Plattenepithelkarzinom des Hypopharynx
- rezidivierendes Plattenepithelkarzinom des Kehlkopfes
Zusätzliche relevante MeSH-Bedingungen
- Neubildungen
- Neubildungen nach Standort
- Kopf-Hals-Neubildungen
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Antimetaboliten, antineoplastisch
- Antimetaboliten
- Antineoplastische Mittel
- Immunsuppressive Mittel
- Immunologische Faktoren
- Tubulin-Modulatoren
- Antimitotische Mittel
- Mitose-Modulatoren
- Antineoplastische Mittel, Phytogen
- Docetaxel
- Paclitaxel
- Fluorouracil
Andere Studien-ID-Nummern
- RTOG-0421
- CDR0000429480
- ECOG-R0421
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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