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NCT01891318 · ClinicalTrials.gov registry record · Phase 1
Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study
A Phase 1 study of Tumors Metastatic to Brain, sponsored by Case Comprehensive Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 2
- Study locations
NCT01891318: Recruiting Phase 1 study of Tumors Metastatic to Brain, sponsored by Case Comprehensive Cancer Center.
NCT01891318 is a Phase 1 study of Tumors Metastatic to Brain that is actively recruiting participants, run by Case Comprehensive Cancer Center. The registered enrollment target is 36 participants, below the 106-participant average among 4 other Tumors Metastatic to Brain trials with a reported enrollment target (66% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01891318, a Phase 1 study of Tumors Metastatic to Brain, is actively recruiting participants, sponsored by Case Comprehensive Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 2
- Study locations
Study Summary
This Phase I/II trial studies the ability to stop brain metastases from coming back after treatment with radiosurgery followed by surgical resection. It will also evaluate the side effects of these combined treatments and help determine the best radiosurgery dose. Radiosurgery focuses the x-rays directly to the tumor and cause less damage to the normal tissue in the brain.
Primary Outcome
MTD of radiosurgery determined by dose-limiting toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 (Phase I)
Conditions Studied
Interventions
- PROCEDURE therapeutic conventional surgery
- RADIATION radiosurgery
- PROCEDURE quality-of-life assessment
Study Locations (2)
Ohio
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center - Cleveland
- Cleveland Clinic, Case Comprehensive Cancer Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2013-07-03 |
| Est. Completion | 2025-12 |
| Phase | Phase 1 |
What NCT01891318 shows while recruiting
NCT01891318 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 106-participant average among 4 other Tumors Metastatic to Brain trials with a reported enrollment target (66% lower).
The record links to 1 condition, with Tumors Metastatic to Brain appearing as the primary indexed condition, and to 3 interventions - of which therapeutic conventional surgery is the first listed.
NCT01891318 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT01891318 about?
NCT01891318 is a clinical study titled "Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study". This Phase I/II trial studies the ability to stop brain metastases from coming back after treatment with radiosurgery followed by surgical resection. It will also evaluate the side effects of these combined treatments and help determine the best radiosurgery dose. Radiosurgery focuses the x-rays dir...
What is the current status of trial NCT01891318?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2013-07-03. Estimated completion is 2025-12.
What conditions does trial NCT01891318 study?
This clinical trial studies the following conditions: Tumors Metastatic to Brain.
What interventions are being tested in trial NCT01891318?
The interventions under investigation include: therapeutic conventional surgery (PROCEDURE), radiosurgery (RADIATION), quality-of-life assessment (PROCEDURE).
Who is sponsoring clinical trial NCT01891318?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01891318 being conducted?
This trial has 2 study locations across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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