Amifostine as a Rectal Protector During External Beam Radiotherapy for Prostate Cancer: A Phase II Study
18 Years
N/A
Male
Prostatic Neoplasms
Trial Information
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.
Inclusion Criteria
- INCLUSION CRITERIA:
Pathologically confirmed adenocarcinoma of the prostate gland.
Age greater than or equal to 18 years.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Informed consent: All patients must sign a document of informed consent indicating their
understanding of the investigational nature and risks of the study before any protocol
related studies are performed (this does not include routine laboratory tests or imaging
studies required to establish eligibility).
EXCLUSION CRITERIA:
Other active malignancy (except for non-melanoma skin cancer).
Patient with a prior history of pelvic or prostate radiotherapy.
Patients with chronic inflammatory bowel disease.
Patients with distant metastatic disease.
Cognitively impaired patients who cannot give informed consent.
Human Immunodeficiency Virus (HIV) positivity.
Other medical conditions deemed by the principal investigator (PI) or associates to make
the patient ineligible for high dose radiotherapy.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
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.
Outcome Description:
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
Outcome Time Frame:
RTOG Acute was used on week 5 and 7
Safety Issue:
Yes
Principal Investigator
Kevin A camphausen, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Cancer Institute (NCI)
Authority:
United States: Federal Government
Study ID:
020215
NCT ID:
NCT00040365
Start Date:
June 2002
Completion Date:
June 2011
Related Keywords:
- Prostatic Neoplasms
- Prostate Cancer
- Radiation Therapy
- Rectal Toxicity
- Amifostine
- Radioprotector
- Neoplasms
- Prostatic Neoplasms
Name | Location |
|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda, Maryland 20892 |
