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NCT01650285 · ClinicalTrials.gov registry record · Phase 2
Cabazitaxel and Radiation For Patients With Prostate Cancer
A Phase 2 study, sponsored by Brown University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT01650285 is a Phase 2 study that was terminated before completion, run by Brown University. The registered enrollment target is 5 participants.
The verdict
NCT01650285, a Phase 2 study, was terminated before completion, sponsored by Brown University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
There is a high relapse rate for patients who have undergone prostatectomy and have pathologic extracapsular prostate extension, positive surgical margins or seminal vesicle involvement (pathologic stage 3 disease). While adjuvant radiation improves progression-free and overall survival, approximately half of these patients will develop recurrence. Similarly, radiation therapy has become the standard salvage therapy for patients with rising PSA \>0.1 - \< 2.0 ng/mL. In common solid tumors such as NSCLC, head and neck cancer and upper gastrointestinal cancers, the addition of chemotherapy to radiation improves survival. It is hypothesized that the addition of radiosensitizing chemotherapy to standard adjuvant radiation will improve survival in patients with stage 3 prostate cancer after prostatectomy and patients with rising PSA \< 2.0 ng.mL without detectable disease. Taxanes are powerful radiation enhancers since they synchronize tumor cells in G2/M the most radiosensitive phase of the cell cycle.17,18 Cabazitaxel is the most active taxane in the treatment of prostate cancer. Therefore, we propose a phase I study establishing the optimal dose of cabazitaxel with adjuvant radiation for stage 3 prostate cancer after prostatectomy (PSA undetectable - \< 2.0 ng/mL). and for patients with persistent or rising PSA post prostatectomy (PSA \>0.1 - \< 2.0 ng/mL).
Interventions
- DRUG Cabazitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2013-01 |
| Est. Completion | 2014-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01650285
The ClinicalTrials.gov registry entry for NCT01650285 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brown University, which has 231 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cabazitaxel is the first listed.
NCT01650285 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01650285 about?
NCT01650285 is a clinical study titled "Cabazitaxel and Radiation For Patients With Prostate Cancer". There is a high relapse rate for patients who have undergone prostatectomy and have pathologic extracapsular prostate extension, positive surgical margins or seminal vesicle involvement (pathologic stage 3 disease). While adjuvant radiation improves progression-free and overall survival, approximate...
What is the current status of trial NCT01650285?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2013-01. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01650285?
The interventions under investigation include: Cabazitaxel (DRUG).
Who is sponsoring clinical trial NCT01650285?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
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