Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003307
Status:
COMPLETED
Last Update Posted:
2010-03-16
First Post:
1999-11-01
Brief Title:
Radiation Therapy Plus Amifostine in Treating Patients With Primary Prostate Cancer
Sponsor:
University of Arizona
Organization:
University of Arizona
Study Overview
Official Title:
A Phase II Open Label Trial of Amifostine Plus Fractionated Radiotherapy for Primary Prostate Adenocarcinoma T1a-T3b NoMo PSA10 ngml to Estimate Acute Grade 2 Genitourinary and Gastrointestinal Toxicity
Status:
COMPLETED
Status Verified Date:
2006-05
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:
RATIONALE Radiation therapy uses high-energy x-rays to damage tumor cells Amifostine may protect normal cells from the side effects of radiation therapy
PURPOSE Phase II trial to study the effectiveness of radiation therapy plus amifostine in treating patients with primary prostate cancer
PURPOSE Phase II trial to study the effectiveness of radiation therapy plus amifostine in treating patients with primary prostate cancer
Detailed Description:
OBJECTIVES I Determine the incidence grade and time course of acute grade 2 or higher gastrointestinal and genitourinary toxicities in patients with primary prostate adenocarcinoma receiving amifostine plus fractionated radiotherapy II Determine the incidence and nature of toxicity associated with amifostine in these patients III Assess tumor response to this treatment in these patients IV Assess impotency rates following radiotherapy in these patients
OUTLINE This is an open label study Patients receive fractionated radiotherapy five days per week for 7 weeks plus amifostine IV push over 5 minutes 15 minutes before each radiation treatment Patients are followed at 1 month after radiotherapy and then every 3 months for at least 5 years
PROJECTED ACCRUAL There will be 25 patients accrued into this study over 2 years
OUTLINE This is an open label study Patients receive fractionated radiotherapy five days per week for 7 weeks plus amifostine IV push over 5 minutes 15 minutes before each radiation treatment Patients are followed at 1 month after radiotherapy and then every 3 months for at least 5 years
PROJECTED ACCRUAL There will be 25 patients accrued into this study over 2 years
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 |
|---|---|---|---|
| NCI-V98-1412 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA023074 |
| P30CA023074 | NIH | None | None |
| UARIZ-HSC-9817 | None | None | None |
| ALZA-98-005-ii | None | None | None |