Amifostine as a Rectal Protector During External Beam Radiotherapy for Prostate Cancer: A Phase II Study
Normal tissue tolerance of the rectum limits the dose of radiation that can be delivered to
the prostate for curative treatment of prostate cancer. Amifostine is a radioprotector, an
agent that reduces tissue damage incurred by ionizing radiation. It has been well studied
in humans and is approved for intravenous use. Rectal administration results in a
preferential accumulation of Amifostine in the rectal mucosa, and neither free parent
compound nor free active metabolite have been detected in systemic circulation. This trial
proposes to observe the rate of early and late bowel toxicity in a group of patients with
prostate cancer receiving standard high dose, 3D conformal external beam radiotherapy and
concurrent intra-rectal applications of Amifostine. Primary measures of rectal toxicity
(RTOG radiation morbidity scoring) will also be compared with self-assessment measures of
quality of life, and rectal radiation dose as assessed by dose-volume histograms.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Percentage of Participants With a Good Toxicity Outcome Who Experienced an Acute Rectal Toxicity and Received Topical Administrations of Amifostine in Conjunction With High Dose, 3D Conformal Radiotherapy for Prostate Cancer.
A good toxicity outcome is defined as having less than grade 2 on both weeks 5 and 7 of treatment. The Radiation Therapy Oncology Group (RTOG) Acute radiation morbidity scoring scheme and the Rectal Mucosal Toxicity response criteria will be used to assess rectal toxicity. The RTOG measures the rectal toxicities. The physician assigns a grade based on symptoms reported by the patient. For details about the RTOG (method and scoring of radiation morbidity, etc.) see http://www.rtog.org/ResearchAssociates/AdverseEventReporting/AcuteRadiationMorbidityScoringCriteria.aspx
RTOG Acute was used on week 5 and 7
Kevin A camphausen, M.D.
National Cancer Institute (NCI)
United States: Federal Government
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