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Amifostine to Protect the Rectum during External Beam Radiotherapy for Prostate Cancer Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Amifostine to Protect the Rectum during External Beam Radiotherapy for Prostate Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Amifostine to Protect the Rectum during External Beam Radiotherapy for Prostate Cancer Clinical research trials and Amifostine to Protect the Rectum during External Beam Radiotherapy for Prostate Cancer medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Amifostine to Protect the Rectum during External Beam Radiotherapy for Prostate Cancer. Amifostine to Protect the Rectum during External Beam Radiotherapy for Prostate Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Amifostine to Protect the Rectum during External Beam Radiotherapy for Prostate Cancer clinical trial. Participants frequently get the best healthcare available for their Amifostine to Protect the Rectum during External Beam Radiotherapy for Prostate Cancer condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > Amifostine to Protect the Rectum during External Beam Radiotherapy for Prostate Cancer  Amifostine to Protect the Rectum during External Beam Radiotherapy for Prostate Cancer
Amifostine to Protect the Rectum during External Beam Radiotherapy for Prostate Cancer
For Condition: Prostatic Neoplasms
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 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 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.
Details: 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, proctoscopic examinations, and rectal radiation dose as assessed by dose-volume histograms.
Eligibility:
Study Type: Interventional,�Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Pathologically confirmed adenocarcinoma of the prostate gland. Age greater than or equal to 18 years. 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. HIV positivity. Other medical conditions deemed by the PI or associates to make the patient ineligible for high dose radiotherapy.
Total Enrollment: 31
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 020215; 02-C-0215
Study Start Date: June 20, 2002
Record last reviewed: May 5, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00040365
Other Prostatic Neoplasms Studies:
1. A Phase IIa. Open-label, Multicenter, Dose-escalation Study to Assess the Tolerability and Pharmacokinetics of ZD4054 Given Orally Once Daily in Subjects with Metastatic Prostate Cancer
2. Phase I/II Dose Escalation Study of VELCADE® and Docetaxel in Patients with Advanced Androgen-Independent Prostate Cancer
3. Using Fiducial Markers to Aid in Prostate Cancer Radiation Treatment
4. Ketoconazole Plus Docetaxel to Treat Prostate Cancer
5. A Phase I Study of Recombinant Vaccinia Virus that Expresses Prostate Specific Antigen in Adult Patients with Adenocarcinoma of the Prostate
Related Studies:
Other Prostatic Neoplasms Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Amifostine to Protect the Rectum during External Beam Radiotherapy for Prostate Cancer
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