Radiation Therapy and Cisplatin With or Without Amifostine for Patients With Stage IIIB or IVA Cervical Cancer

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

August 31, 2001

Primary Completion Date

September 30, 2007

Study Completion Date

June 30, 2010

Conditions
Cervical CancerRadiation Toxicity
Interventions
DRUG

Amifostine trihydrate

Amifostine will be delivered before each radiation treatment. Amifostine (500 mg) will be given as two equally-divided subcutaneous injections.

DRUG

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.

RADIATION

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.

RADIATION

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%.

Trial Locations (17)

15219

Mercy Cancer Institute at Mercy Hospital, Pittsburgh

32073

Florida Oncology Associates, Orange Park

32086

Flagler Cancer Center, Saint Augustine

32177

Florida Cancer Center - Palatka, Palatka

32207

Baptist Cancer Institute - Jacksonville, Jacksonville

Florida Oncology Associates at Southside Cancer Center, Jacksonville

32250

Integrated Community Oncology Network, Jacksonville Beach

32258

Baptist Medical Center South, Jascksonville

44691

Cancer Treatment Center, Wooster

49001

Borgess Medical Center, Kalamazooaa

49007

Bronson Methodist Hospital, Kalamazoo

89102

University Medical Center of Southern Nevada, Las Vegas

89106

CCOP - Nevada Cancer Research Foundation, Las Vegas

49007-3731

West Michigan Cancer Center, Kalamazoo

08053

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton, Marlton

08360

Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare, Vineland

44309-2090

Akron City Hospital, Akron

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Radiation Therapy Oncology Group

NETWORK

NCT00012012 - Radiation Therapy and Cisplatin With or Without Amifostine for Patients With Stage IIIB or IVA Cervical Cancer | Biotech Hunter | Biotech Hunter