Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06649058 · ClinicalTrials.gov registry record · Phase 2
EXCLAIM: Exploring Combined Local and Systemic Approaches In Brain Metastasis: a Multi-cohort Randomized Phase II Study Evaluating Initial Response to Systemic Therapy and Subsequent Integration of Stereotactic Radiosurgery in Patients With Low-risk Brain Metastases and Central Nervous System-active
A Phase 2 study of Brain Metastases, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 316
- Enrollment target
- 1
- Study location
NCT06649058: Recruiting Phase 2 study of Brain Metastases, sponsored by M.D. Anderson Cancer Center.
NCT06649058 is a Phase 2 study of Brain Metastases that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 316 participants, above the 208-participant average among 67 other Brain Metastases trials with a reported enrollment target (52% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06649058, a Phase 2 study of Brain Metastases, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 316 participants
- Enrollment target
- 1
- Study location
Study Summary
To learn if consolidative stereotactic radiosurgery (cSRS) can help to control central nervous system (CNS) disease in patients who have brain metastases and have a partial response or stable brain metastases after systemic therapy. To learn if using SRS to treat all brain metastases that do not respond to systemic therapy versus treating only metastases that are getting worse can help to control CNS disease in patients whose disease gets worse after systemic therapy.
Primary Outcome
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Conditions Studied
Interventions
- RADIATION Stereotactic Radiosurgery
- OTHER Systemic Therapy
Study Locations (1)
Texas
- The University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 316 participants |
| Start Date | 2025-02-14 |
| Est. Completion | 2030-09-30 |
| Phase | Phase 2 |
What NCT06649058 shows while recruiting
NCT06649058 is an interventional study that assigns participants to a tested intervention. The registered 316 participants enrollment target is mid-sized for trials with a published cap, above the 208-participant average among 67 other Brain Metastases trials with a reported enrollment target (52% higher).
The record links to 1 condition, with Brain Metastases appearing as the primary indexed condition, and to 2 interventions - of which Stereotactic Radiosurgery is the first listed.
NCT06649058 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06649058 about?
NCT06649058 is a clinical study titled "EXCLAIM: Exploring Combined Local and Systemic Approaches In Brain Metastasis: a Multi-cohort Randomized Phase II Study Evaluating Initial Response to Systemic Therapy and Subsequent Integration of Stereotactic Radiosurgery in Patients With Low-risk Brain Metastases and Central Nervous System-active". To learn if consolidative stereotactic radiosurgery (cSRS) can help to control central nervous system (CNS) disease in patients who have brain metastases and have a partial response or stable brain metastases after systemic therapy. To learn if using SRS to treat all brain metastases that do not re...
What is the current status of trial NCT06649058?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 316 participants. The study started on 2025-02-14. Estimated completion is 2030-09-30.
What conditions does trial NCT06649058 study?
This clinical trial studies the following conditions: Brain Metastases.
What interventions are being tested in trial NCT06649058?
The interventions under investigation include: Stereotactic Radiosurgery (RADIATION), Systemic Therapy (OTHER).
Who is sponsoring clinical trial NCT06649058?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06649058 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Brain Metastases
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 NCT06649058's enrollment target sits among peer trials
316 2nd of 67 the highest of 67 other Brain Metastases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Brain Metastases 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Frameless Stereotactic Radiosurgery for Intact Brain Metastases
RECRUITING · Phase 2
-
Feasibility of 18F-Fluciclovine PET/CT to Identify Brain Metastasis
RECRUITING · Phase 2
-
Optimizing Neurocognition With Whole Brain Radiation Therapy (WBRT) Using Upfront Pulsed Reduced Dose-Rate (PRDR) Technique
RECRUITING · Phase 2
-
Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance
RECRUITING · Phase 2
-
Phase II Study of Pembrolizumab in Combination With Lenvatinib in Patients With TNBC, NSCLC, and Other Tumor Types and Brain Metastases
RECRUITING · Phase 2
-
A Phase II Study of Tucatinib and Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2-positive Metastatic Solid Tumors and Metastases to Brain (TUCATEMEB)
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04256317 · 316 participants · Phase 2
A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)
- NCT04787042 · 316 participants · Phase 1
Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067
- NCT04802759 · 316 participants · Phase 1
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer
- NCT05464056 · 316 participants · NA
BUILT Family Lifestyle Program for Children with ADHD
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI