Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040365
Status:
COMPLETED
Last Update Posted:
2012-04-30
First Post:
2002-06-25
Brief Title:
Amifostine to Protect the Rectum During External Beam Radiotherapy for Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Amifostine as a Rectal Protector During External Beam Radiotherapy for Prostate Cancer A Phase II Study
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-C-0215 | None | None | None |