45
Participants
Start Date
August 31, 2001
Primary Completion Date
September 30, 2007
Study Completion Date
June 30, 2010
Amifostine trihydrate
Amifostine will be delivered before each radiation treatment. Amifostine (500 mg) will be given as two equally-divided subcutaneous injections.
Cisplatin
Cisplatin will be given weekly with external beam radiation therapy and once with brachytherapy for a total of six doses. Patients receive 40 mg/m\^2 by IV over 30-60 minutes on days 1, 8, 15, 22, 29, and 36.
Intracavitary brachytherapy
For low dose rate (LDR) brachytherapy, cesium will be given in one to two intracavitary applications, within two weeks of completion of external radiation. The interval between the two applications will be one to three weeks. It is recommended that the total course of treatment be completed in less than eight weeks. High dose rate (HDR) brachytherapy may start as early as week two of external radiation. The minimum cumulative external and intracavitary dose should be 85 Gy.
External beam radiation therapy
Patients will receive 1.8 Gy daily for five weeks for a total dose of 45 Gy; involved lateral parametrium and/or pelvic nodes should be boosted for a total dose (including intracavitary treatment) of 60 Gy ± 5%.
Mercy Cancer Institute at Mercy Hospital, Pittsburgh
Florida Oncology Associates, Orange Park
Flagler Cancer Center, Saint Augustine
Florida Cancer Center - Palatka, Palatka
Baptist Cancer Institute - Jacksonville, Jacksonville
Florida Oncology Associates at Southside Cancer Center, Jacksonville
Integrated Community Oncology Network, Jacksonville Beach
Baptist Medical Center South, Jascksonville
Cancer Treatment Center, Wooster
Borgess Medical Center, Kalamazooaa
Bronson Methodist Hospital, Kalamazoo
University Medical Center of Southern Nevada, Las Vegas
CCOP - Nevada Cancer Research Foundation, Las Vegas
West Michigan Cancer Center, Kalamazoo
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton, Marlton
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare, Vineland
Akron City Hospital, Akron
National Cancer Institute (NCI)
NIH
Radiation Therapy Oncology Group
NETWORK