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NCT00040365 · ClinicalTrials.gov registry record · Phase 2
Amifostine to Protect the Rectum During External Beam Radiotherapy for Prostate Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT00040365: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00040365 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00040365, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
This study will evaluate the safety and effectiveness of a drug called amifostine in reducing the bowel side effects of radiation treatment for prostate cancer. Amifostine is a 'radioprotector' medicine that to protects normal tissue from radiation damage. This study will determine whether placing amifostine in the rectum during radiation treatment for prostate cancer can decrease common side effects of treatment, including diarrhea, painful bowel movements, bleeding, and gas. Patients 18 years of age or older with prostate cancer may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood tests, bone scan if a recent one is not available, and possibly computed tomography (CT) and magnetic resonance imaging (MRI) scans of the pelvis. They will also have a liquid retention test, in which they are given an enema of 4 tablespoons of salt water that they must retain for 20 minutes. Participants will receive standard radiation therapy for prostate cancer-5 consecutive days for 8 weeks-in the National Institutes of Health (NIH) Radiation Oncology Clinic. Amifostine will be placed in the rectum by a mini-enema before each radiation treatment so that it covers the lining of the rectum. To determine the side effects of the treatment, patients will undergo a proctoscopic examination before beginning radiation therapy, two times during therapy, and at each follow-up visit for 5 years after treatment ends. This examination involves inserting a proctoscope (a thin flexible tube with a light at the end) into the rectum and taking pictures. Patients will be followed in the clinic at visits scheduled 1, 3, 6, 12, 18, 24, 36, 48, and 60 months after treatment for a physical examination and routine blood tests, proctoscopic examination, and review of bowel symptoms.
Interventions
- RADIATION Radiation therapy
- DRUG Amifostine trihydrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2002-06 |
| Est. Completion | 2011-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00040365
The ClinicalTrials.gov registry entry for NCT00040365 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Radiation therapy is the first listed.
NCT00040365 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00040365 about?
NCT00040365 is a clinical study titled "Amifostine to Protect the Rectum During External Beam Radiotherapy for Prostate Cancer". This study will evaluate the safety and effectiveness of a drug called amifostine in reducing the bowel side effects of radiation treatment for prostate cancer. Amifostine is a 'radioprotector' medicine that to protects normal tissue from radiation damage. This study will determine whether placing a...
What is the current status of trial NCT00040365?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2002-06. Estimated completion is 2011-06.
What interventions are being tested in trial NCT00040365?
The interventions under investigation include: Radiation therapy (RADIATION), Amifostine trihydrate (DRUG).
Who is sponsoring clinical trial NCT00040365?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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