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NCT04114981 · ClinicalTrials.gov registry record · Phase 3
Single Fraction Stereotactic Radiosurgery Compared With Fractionated Stereotactic Radiosurgery in Treating Patients With Resected Metastatic Brain Disease
A Phase 3 study of Metastatic Malignant Neoplasm in the Brain, sponsored by Alliance for Clinical Trials in Oncology.
- Active
- Registry status
- Phase 3
- Development phase
- 242
- Enrollment target
- 20
- Study locations
NCT04114981: Active Phase 3 study of Metastatic Malignant Neoplasm in the Brain, sponsored by Alliance for Clinical Trials in Oncology.
NCT04114981 is a Phase 3 study of Metastatic Malignant Neoplasm in the Brain that is active but no longer recruiting, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 242 participants, above the 82-participant average among 43 other Metastatic Malignant Neoplasm in the Brain trials with a reported enrollment target (195% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04114981, a Phase 3 study of Metastatic Malignant Neoplasm in the Brain, is active but no longer recruiting, sponsored by Alliance for Clinical Trials in Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 242 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial studies how well single fraction stereotactic radiosurgery works compared with fractionated stereotactic radiosurgery in treating patients with cancer that has spread to the brain from other parts of the body and has been removed by surgery. Single fraction stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Fractionated stereotactic radiosurgery delivers multiple, smaller doses of radiation therapy over time. This study may help doctors find out if fractionated stereotactic radiosurgery is better or worse than the usual approach with single fraction stereotactic radiosurgery.
Primary Outcome
Surgical bed control is defined as the absence of new nodular contrast enhancement in the surgical bed. In other words, a surgical bed recurrence-free survival (SB-RFS) event is defined as radiographic evidence of a new contrast-enhancing lesion (specifically any new progressive enhancing nodularity) at the site of the surgical resection. Will use a stratified log-rank test that compares and will report the median SB-RFS times between the single fraction stereotactic radiosurgery (SSRS) and frac
Conditions Studied
Interventions
- OTHER Questionnaire Administration
- PROCEDURE Quality-of-Life Assessment
- RADIATION Single Fraction Stereotactic Radiosurgery
- RADIATION Fractionated Stereotactic Radiosurgery
Study Locations (20)
Arizona
- Banner MD Anderson Cancer Center - Gilbert
- Banner Thunderbird Medical Center - Glendale
- Banner-University Medical Center Phoenix - Phoenix
- Mayo Clinic Hospital in Arizona - Phoenix
- Mayo Clinic in Arizona - Scottsdale
- University of Arizona Cancer Center-North Campus - Tucson
California
- UC San Diego Moores Cancer Center - La Jolla
- Los Angeles County-USC Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- Epic Care Cyberknife Center - Walnut Creek
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
Colorado
- University of Colorado Hospital - Aurora
- UCHealth Memorial Hospital Central - Colorado Springs
Delaware
- Helen F Graham Cancer Center - Newark
- Beebe Health Campus - Rehoboth Beach
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Alaska
- Anchorage Radiation Therapy Center - Anchorage
Connecticut
- Yale University - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 242 participants |
| Start Date | 2019-11-19 |
| Est. Completion | 2028-03 |
| Phase | Phase 3 |
What the registry record for NCT04114981 still lists
NCT04114981 is an interventional study that assigns participants to a tested intervention. The registered 242 participants enrollment target is mid-sized for trials with a published cap, above the 82-participant average among 43 other Metastatic Malignant Neoplasm in the Brain trials with a reported enrollment target (195% 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 Questionnaire Administration is the first listed.
NCT04114981 names 20 study sites across 9 states, led by Arizona, California, Arkansas.
Frequently Asked Questions
What is clinical trial NCT04114981 about?
NCT04114981 is a clinical study titled "Single Fraction Stereotactic Radiosurgery Compared With Fractionated Stereotactic Radiosurgery in Treating Patients With Resected Metastatic Brain Disease". This phase III trial studies how well single fraction stereotactic radiosurgery works compared with fractionated stereotactic radiosurgery in treating patients with cancer that has spread to the brain from other parts of the body and has been removed by surgery. Single fraction stereotactic radiosur...
What is the current status of trial NCT04114981?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 242 participants. The study started on 2019-11-19. Estimated completion is 2028-03.
What conditions does trial NCT04114981 study?
This clinical trial studies the following conditions: Metastatic Malignant Neoplasm in the Brain.
What interventions are being tested in trial NCT04114981?
The interventions under investigation include: Questionnaire Administration (OTHER), Quality-of-Life Assessment (PROCEDURE), Single Fraction Stereotactic Radiosurgery (RADIATION), Fractionated Stereotactic Radiosurgery (RADIATION).
Who is sponsoring clinical trial NCT04114981?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04114981 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04114981's enrollment target sits among peer trials
242 3rd of 43 higher than 41 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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