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NCT06500455 · ClinicalTrials.gov registry record · Phase 3
Testing Longer Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With Cancer That Has Spread to the Brain
A Phase 3 study of Metastatic Malignant Solid Neoplasm and Metastatic Melanoma, sponsored by NRG Oncology.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 269
- Enrollment target
- 20
- Study locations
NCT06500455: Recruiting Phase 3 study of Metastatic Malignant Solid Neoplasm and Metastatic Melanoma, sponsored by NRG Oncology.
NCT06500455 is a Phase 3 study of Metastatic Malignant Solid Neoplasm and Metastatic Melanoma that is actively recruiting participants, run by NRG Oncology. The registered enrollment target is 269 participants, above the 203-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (33% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06500455, a Phase 3 study of Metastatic Malignant Solid Neoplasm and Metastatic Melanoma, is actively recruiting participants, sponsored by NRG Oncology.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 269 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial compares the effectiveness of fractionated stereotactic radiosurgery (FSRS) to usual care stereotactic radiosurgery (SRS) in treating patients with cancer that has spread from where it first started to the brain. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. FSRS delivers a high dose of radiation to the tumor over 3 treatments. SRS is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. FSRS may be more effective compared to SRS in treating patients with cancer that has spread to the brain.
Primary Outcome
The time to local failure will be evaluated at a per-patient level. The cause-specific hazard ratio will be estimated in a Cox proportional hazards (PH) model adjusting for patients and disease characteristics. The Cox PH model will be the principle approach. The cumulative incidence function estimator will also be used to estimate the rate of local failure in the presence of competing event of deaths in the two arms separately. A complementary analysis will involve Gray's test to evaluate the d
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- RADIATION Stereotactic Radiosurgery
- RADIATION Fractionated Stereotactic Radiation Therapy
Study Locations (20)
California
- Kaiser Permanente-Anaheim - Anaheim
- Kaiser Permanente-Bellflower - Bellflower
- City of Hope Corona - Corona
- City of Hope Comprehensive Cancer Center - Duarte
- UC San Diego Health System - Encinitas - Encinitas
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- City of Hope at Irvine Lennar - Irvine
- UC San Diego Moores Cancer Center - La Jolla
- City of Hope Antelope Valley - Lancaster
- Kaiser Permanente Los Angeles Medical Center - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- Providence Queen of The Valley - Napa
- Kaiser Permanente-Ontario - Ontario
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- Stanford Cancer Institute Palo Alto - Palo Alto
- UC San Diego Medical Center - Hillcrest - San Diego
- Providence Medical Foundation - Santa Rosa - Santa Rosa
Arizona
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 269 participants |
| Start Date | 2024-12-12 |
| Est. Completion | 2028-06-30 |
| Phase | Phase 3 |
What NCT06500455 shows while recruiting
NCT06500455 is an interventional study that assigns participants to a tested intervention. The registered 269 participants enrollment target is mid-sized for trials with a published cap, above the 203-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (33% higher).
The record links to 10 conditions, with Metastatic Malignant Solid Neoplasm appearing as the primary indexed condition, and to 4 interventions - of which Computed Tomography is the first listed.
NCT06500455 names 20 study sites across 3 states, led by California, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT06500455 about?
NCT06500455 is a clinical study titled "Testing Longer Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With Cancer That Has Spread to the Brain". This phase III trial compares the effectiveness of fractionated stereotactic radiosurgery (FSRS) to usual care stereotactic radiosurgery (SRS) in treating patients with cancer that has spread from where it first started to the brain. Radiation therapy uses high energy x-rays to kill tumor cells and ...
What is the current status of trial NCT06500455?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 269 participants. The study started on 2024-12-12. Estimated completion is 2028-06-30.
What conditions does trial NCT06500455 study?
This clinical trial studies the following conditions: Metastatic Malignant Solid Neoplasm, Metastatic Melanoma, Stage IV Lung Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Malignant Neoplasm in the Brain.
What interventions are being tested in trial NCT06500455?
The interventions under investigation include: Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Stereotactic Radiosurgery (RADIATION), Fractionated Stereotactic Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT06500455?
This trial is sponsored by NRG Oncology, which has 64 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06500455 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California. 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 NCT06500455's enrollment target sits among peer trials
269 10th of 92 higher than 83 of 92 other Metastatic Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Malignant Solid Neoplasm 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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