Amifostine to Protect the Rectum During External Beam Radiotherapy for Prostate Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

June 30, 2002

Primary Completion Date

May 31, 2010

Study Completion Date

June 30, 2011

Conditions
Prostatic Neoplasms
Interventions
DRUG

Amifostine trihydrate

1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).

RADIATION

Radiation therapy

The treatment will be delivered in at least two phases. The first field reduction will occur after 46Gy and the second field reduction will occur after 70Gy.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT00040365 - Amifostine to Protect the Rectum During External Beam Radiotherapy for Prostate Cancer | Biotech Hunter | Biotech Hunter