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NCT01950351 · ClinicalTrials.gov registry record · Phase 1
Hypofractionated Proton Beam Therapy for Localized Prostate Cancer
A Phase 1 study of Stage II Prostate Adenocarcinoma AJCC v7 and Stage I Prostate Adenocarcinoma AJCC v7, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 241
- Enrollment target
- 1
- Study location
NCT01950351: Active Phase 1 study of Stage II Prostate Adenocarcinoma AJCC v7 and Stage I Prostate Adenocarcinoma AJCC v7, sponsored by M.D. Anderson Cancer Center.
NCT01950351 is a Phase 1 study of Stage II Prostate Adenocarcinoma AJCC v7 and Stage I Prostate Adenocarcinoma AJCC v7 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 241 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (302% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01950351, a Phase 1 study of Stage II Prostate Adenocarcinoma AJCC v7 and Stage I Prostate Adenocarcinoma AJCC v7, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 241 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies the side effects and how well hypofractionated proton beam radiation therapy works in treating patients with prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Specialized radiation therapy, such as proton beam radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
Primary Outcome
The cumulative incidence of late grade 2 or greater GI toxicity will be estimated with a 95% confidence interval.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Laboratory Biomarker Analysis
- RADIATION Proton Beam Radiation Therapy
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 241 participants |
| Start Date | 2013-10-10 |
| Est. Completion | 2028-06-01 |
| Phase | Phase 1 |
What the registry record for NCT01950351 still lists
NCT01950351 is an interventional study that assigns participants to a tested intervention. The registered 241 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (302% higher).
The record links to 2 conditions, with Stage II Prostate Adenocarcinoma AJCC v7 appearing as the primary indexed condition, and to 3 interventions - of which Quality-of-Life Assessment is the first listed.
NCT01950351 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01950351 about?
NCT01950351 is a clinical study titled "Hypofractionated Proton Beam Therapy for Localized Prostate Cancer". This phase II trial studies the side effects and how well hypofractionated proton beam radiation therapy works in treating patients with prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Specialized radiation therapy, such as proton beam radiation therapy, that...
What is the current status of trial NCT01950351?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 241 participants. The study started on 2013-10-10. Estimated completion is 2028-06-01.
What conditions does trial NCT01950351 study?
This clinical trial studies the following conditions: Stage II Prostate Adenocarcinoma AJCC v7, Stage I Prostate Adenocarcinoma AJCC v7.
What interventions are being tested in trial NCT01950351?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Laboratory Biomarker Analysis (OTHER), Proton Beam Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT01950351?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01950351 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01950351's enrollment target sits among peer trials
241 196th of 2000 higher than 1,804 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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