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NCT01288534 · ClinicalTrials.gov registry record · Phase 2
Hypofractionated Stereotactic Body Radiation Therapy (SBRT)
A Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 68
- Enrollment target
NCT01288534 is a Phase 2 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 68 participants.
The verdict
NCT01288534, a Phase 2 study, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 68 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and tolerability of using radiation therapy with 5 fractions of radiation to treat prostate cancer with guidance of radiation using the Calypso 4D Treatment System (Calypso).A number of recent studies have used 5 radiation fraction to treat prostate cancer over 2-3 weeks as compared to the typical treatment which would involve 40-42 smaller radiation fractions over 8-9 weeks. This type of radiation using a smaller number of treatments has been called hypofractionated radiation therapy. The Calypso is a new technique which uses beacons implanted into the prostate which using radio signals are able to localize and track the position of the prostate continuously during radiation therapy. The Calypso system has been approved by the United States Food and Drug Administration (FDA) for guidance of radiation therapy during the treatment of prostate cancer and is being utilized all across the United States. However, it has not been tested for hypofractionated radiation therapy.
Interventions
- RADIATION Radiation Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2011-01 |
| Est. Completion | 2016-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01288534
The ClinicalTrials.gov registry entry for NCT01288534 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan Rogel Cancer Center, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Radiation Therapy is the first listed.
NCT01288534 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01288534 about?
NCT01288534 is a clinical study titled "Hypofractionated Stereotactic Body Radiation Therapy (SBRT)". The purpose of this study is to evaluate the safety and tolerability of using radiation therapy with 5 fractions of radiation to treat prostate cancer with guidance of radiation using the Calypso 4D Treatment System (Calypso).A number of recent studies have used 5 radiation fraction to treat prostat...
What is the current status of trial NCT01288534?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2011-01. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01288534?
The interventions under investigation include: Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT01288534?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
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