Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00214097
Status:
COMPLETED
Last Update Posted:
2019-11-25
First Post:
2005-09-13
Brief Title:
Phase III Hypofractionated Radiotherapy for Prostate Cancer
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Phase III Trial Examining Dose-per-Fraction Escalation Using Intensity Modulated Radiation Therapy in the Treatment of Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2019-09
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:
The purpose of this study is to examine the clinical feasibility of using Intensity-modulated radiation therapy IMRT combined with daily pretreatment prostate localization to deliver increasingly hypofractionated treatment courses Progressively larger fraction sizes will be delivered in a phase I design based on both acute and long-term tolerances to the treatment The dose-per-fraction escalation design utilizes schemas that maintain an isoeffective dose for late effects while predicting that tumor control will actually improve The delivery of fewer larger fractions of radiation if proven effective and safe would result in significant cost saving and more efficient use of resources Phase II will commence with Maximum Tolerated Dose MTD finding with up to 200 additional patients being enrolled during this phase of the study
Detailed Description:
None
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 P01 CA88960 | None | None | None |
| 2002-322 | OTHER | None | None |
| A533300 | OTHER | None | None |
| SMPHHUMAN ONCOLOGY | OTHER | UW Madison | None |