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NCT00214097 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Hypofractionated Radiotherapy for Prostate Cancer
A Phase 1 study of Prostate Cancer, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 1
- Development phase
- 347
- Enrollment target
- 1
- Study location
NCT00214097 is a Phase 1 study of Prostate Cancer that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 347 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (43% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00214097, a Phase 1 study of Prostate Cancer, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 347 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- RADIATION Radiotherapy
Study Locations (1)
Wisconsin
- University of Wisconsin Hospital and Clinics - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 347 participants |
| Start Date | 2002-10-14 |
| Est. Completion | 2017-08-21 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00214097
The ClinicalTrials.gov registry entry for NCT00214097 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 347 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (43% lower). The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which Radiotherapy is the first listed.
NCT00214097 reports 1 study location spanning 1 distinct geographic area - top geographies include Wisconsin.
Frequently Asked Questions
What is clinical trial NCT00214097 about?
NCT00214097 is a clinical study titled "Phase I/II Hypofractionated Radiotherapy for Prostate Cancer". 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...
What is the current status of trial NCT00214097?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 347 participants. The study started on 2002-10-14. Estimated completion is 2017-08-21.
What conditions does trial NCT00214097 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT00214097?
The interventions under investigation include: Radiotherapy (RADIATION).
Who is sponsoring clinical trial NCT00214097?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00214097 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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