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NCT05438212 · ClinicalTrials.gov registry record · Phase 3
Comparing the Addition of Radiation Either Before or After Surgery for Patients With Brain Metastases
A Phase 3 study of Metastatic Malignant Neoplasm in the Brain, sponsored by NRG Oncology.
- Active
- Registry status
- Phase 3
- Development phase
- 237
- Enrollment target
- 20
- Study locations
NCT05438212: Active Phase 3 study of Metastatic Malignant Neoplasm in the Brain, sponsored by NRG Oncology.
NCT05438212 is a Phase 3 study of Metastatic Malignant Neoplasm in the Brain that is active but no longer recruiting, run by NRG Oncology. The registered enrollment target is 237 participants, above the 83-participant average among 43 other Metastatic Malignant Neoplasm in the Brain trials with a reported enrollment target (186% higher). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05438212, a Phase 3 study of Metastatic Malignant Neoplasm in the Brain, is active but no longer recruiting, sponsored by NRG Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 237 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial compares the usual treatment of surgery after stereotactic radiosurgery (SRS) to receiving SRS before surgery in treating patients with cancer that has spread to the brain (brain metastases). Stereotactic radiosurgery is a type of radiation therapy that delivers a high dose of radiation to target tumors and minimizes effect on normal surrounding brain tissue. The combination of surgery and radiation may stop the tumor from growing for a few months or longer and may reduce symptoms of brain metastases. This study investigates whether treating with SRS before surgery may be better than SRS after surgery in reducing the possibility of the tumor coming back, reducing or preventing the cancer from spreading to other areas of the brain and reducing the risk of scarring on the brain from radiation.
Primary Outcome
Analysis for this endpoint will consist of testing the cause-specific hazard ratio in a Cox proportional hazards model.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- RADIATION Stereotactic Radiosurgery
- PROCEDURE Brain Surgery
Study Locations (20)
California
- Kaiser Permanente-Anaheim - Anaheim
- Sutter Auburn Faith Hospital - Auburn
- Sutter Cancer Centers Radiation Oncology Services-Auburn - Auburn
- Kaiser Permanente-Bellflower - Bellflower
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- Kaiser Permanente Los Angeles Medical Center - Los Angeles
- Memorial Medical Center - Modesto
- Kaiser Permanente-Ontario - Ontario
- Saint Joseph Hospital - Orange - Orange
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- Stanford Cancer Institute Palo Alto - Palo Alto
- Sutter Cancer Centers Radiation Oncology Services-Roseville - Roseville
- Sutter Roseville Medical Center - Roseville
- Sutter Medical Center Sacramento - Sacramento
- University of California Davis Comprehensive Cancer Center - Sacramento
- California Pacific Medical Center-Pacific Campus - San Francisco
- UCSF Medical Center-Parnassus - San Francisco
Arizona
- Saint Joseph's Hospital and Medical Center - Phoenix
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 237 participants |
| Start Date | 2022-10-24 |
| Est. Completion | 2027-03-16 |
| Phase | Phase 3 |
What the registry record for NCT05438212 still lists
NCT05438212 is an interventional study that assigns participants to a tested intervention. The registered 237 participants enrollment target is mid-sized for trials with a published cap, above the 83-participant average among 43 other Metastatic Malignant Neoplasm in the Brain trials with a reported enrollment target (186% higher).
The record links to 1 condition, with Metastatic Malignant Neoplasm in the Brain appearing as the primary indexed condition, and to 4 interventions - of which Quality-of-Life Assessment is the first listed.
NCT05438212 names 20 study sites across 2 states, led by California, Arizona.
Frequently Asked Questions
What is clinical trial NCT05438212 about?
NCT05438212 is a clinical study titled "Comparing the Addition of Radiation Either Before or After Surgery for Patients With Brain Metastases". This phase III trial compares the usual treatment of surgery after stereotactic radiosurgery (SRS) to receiving SRS before surgery in treating patients with cancer that has spread to the brain (brain metastases). Stereotactic radiosurgery is a type of radiation therapy that delivers a high dose of r...
What is the current status of trial NCT05438212?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 237 participants. The study started on 2022-10-24. Estimated completion is 2027-03-16.
What conditions does trial NCT05438212 study?
This clinical trial studies the following conditions: Metastatic Malignant Neoplasm in the Brain.
What interventions are being tested in trial NCT05438212?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Stereotactic Radiosurgery (RADIATION), Brain Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT05438212?
This trial is sponsored by NRG Oncology, which has 64 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05438212 being conducted?
This trial has 20 study locations across Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic Malignant Neoplasm in the Brain
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 NCT05438212's enrollment target sits among peer trials
237 4th of 43 higher than 40 of 43 other Metastatic Malignant Neoplasm in the Brain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Malignant Neoplasm in the Brain 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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