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NCT00377156 · ClinicalTrials.gov registry record · Phase 3
Stereotactic Radiation Therapy With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
A Phase 3 study of Breast Cancer and Prostate Cancer, sponsored by Alliance for Clinical Trials in Oncology.
- Completed
- Registry status
- Phase 3
- Development phase
- 213
- Enrollment target
- 20
- Study locations
NCT00377156: Completed Phase 3 study of Breast Cancer and Prostate Cancer, sponsored by Alliance for Clinical Trials in Oncology.
NCT00377156 is a Phase 3 study of Breast Cancer and Prostate Cancer that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 213 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00377156, a Phase 3 study of Breast Cancer and Prostate Cancer, has completed, sponsored by Alliance for Clinical Trials in Oncology.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 213 participants
- Enrollment target
- 20
- Study locations
Study Summary
RATIONALE: Stereotactic radiation therapy can send x-rays directly to the tumor and cause less damage to normal tissue. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether stereotactic radiation therapy is more effective with or without whole-brain radiation therapy in treating patients with brain metastases. PURPOSE: This randomized phase III trial is studying stereotactic radiation therapy and whole-brain radiation therapy to see how well they work compared with stereotactic radiation therapy alone in treating patients with brain metastases.
Primary Outcome
The primary endpoint was cognitive deterioration (progression), defined as a decline of greater than 1 SD from baseline on at least 1 of 7 cognitive tests (all tests are standardized based on published norms and transformed so that higher values represent improved cognition) at the 3-month post-SRS evaluation. The number of participants who experienced cognitive deterioration by 3 months is reported for each arm below. For primary analysis of the 3-month cognitive deterioration endpoint, the Fis
Conditions Studied
Interventions
- RADIATION radiation therapy
- RADIATION stereotactic radiosurgery
Study Locations (20)
California
- Memorial Medical Center - Modesto
- Kaiser Permanente - Division of Research - Oakland - Oakland
- St. Joseph Hospital Regional Cancer Center - Orange - Orange
- Rohnert Park Cancer Center - Rohnert Park
- Kaiser Permanente Medical Center - Santa Clara Kiely Campus - Santa Clara
- Kaiser Permanente Medical Center - Santa Rosa - Santa Rosa
Georgia
- Northside Hospital Cancer Center - Atlanta
- Saint Joseph's Hospital of Atlanta - Atlanta
- Northeast Georgia Medical Center - Gainesville
- Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler - Savannah
Arizona
- Arizona Oncology-Deer Valley Center - Phoenix
- Arizona Oncology Services Foundation - Scottsdale
Colorado
- University of Colorado Cancer Center at UC Health Sciences Center - Aurora
- Veterans Affairs Medical Center - Denver - Denver
Florida
- Mayo Clinic - Jacksonville - Jacksonville
- Florida Hospital Cancer Institute at Florida Hospital Orlando - Orlando
Idaho
- Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center - Boise
Illinois
- Northwest Community Hospital - Arlington Heights
Kansas
- Via Christi Cancer Center at Via Christi Regional Medical Center - Wichita
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 213 participants |
| Start Date | 2006-07 |
| Est. Completion | 2019-12-15 |
| Phase | Phase 3 |
What the finished NCT00377156 record still lists
NCT00377156 is an interventional study that assigns participants to a tested intervention. The registered 213 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (92% lower).
The record links to 5 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which radiation therapy is the first listed.
NCT00377156 names 20 study sites across 9 states, led by California, Georgia, Arizona.
Frequently Asked Questions
What is clinical trial NCT00377156 about?
NCT00377156 is a clinical study titled "Stereotactic Radiation Therapy With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases". RATIONALE: Stereotactic radiation therapy can send x-rays directly to the tumor and cause less damage to normal tissue. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether stereotactic radiation therapy is more effective with or without whole-brain radiation th...
What is the current status of trial NCT00377156?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 213 participants. The study started on 2006-07. Estimated completion is 2019-12-15.
What conditions does trial NCT00377156 study?
This clinical trial studies the following conditions: Breast Cancer, Prostate Cancer, Lung Cancer, Metastatic Cancer, Cognitive/Functional Effects.
What interventions are being tested in trial NCT00377156?
The interventions under investigation include: radiation therapy (RADIATION), stereotactic radiosurgery (RADIATION).
Who is sponsoring clinical trial NCT00377156?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00377156 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00377156's enrollment target sits among peer trials
213 351st of 1224 higher than 873 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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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