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NCT01644591 · ClinicalTrials.gov registry record · Phase 2
Stereotactic Radiosurgery in Treating Patients With Greater Than 3 Melanoma Brain Metastases
A Phase 2 study of Metastatic Melanoma and Metastatic Malignant Neoplasm in the Brain, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
- 1
- Study location
NCT01644591: Active Phase 2 study of Metastatic Melanoma and Metastatic Malignant Neoplasm in the Brain, sponsored by M.D. Anderson Cancer Center.
NCT01644591 is a Phase 2 study of Metastatic Melanoma and Metastatic Malignant Neoplasm in the Brain that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 49 participants, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (41% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01644591, a Phase 2 study of Metastatic Melanoma and Metastatic Malignant Neoplasm in the Brain, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well stereotactic radiosurgery works in treating patients with melanoma that has spread to more than 3 places in the brain. 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.
Primary Outcome
Time to local failure will be estimated using the product-limit estimator of Kaplan and Meier, and log-rank test will be used for comparison of local failure rate in patients treated with stereotactic radiosurgery (SRS) to null hypothesis with respect to the time to local failure. Patients who are lost to follow-up or who die from distant disease before having local failure will be censored. Local control rates at 4 months may be estimated with 95% confidence intervals using Kaplan-Meier method.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- RADIATION Stereotactic Radiosurgery
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2012-08-02 |
| Est. Completion | 2026-08-31 |
| Phase | Phase 2 |
What the registry record for NCT01644591 still lists
NCT01644591 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (41% lower).
The record links to 4 conditions, with Metastatic Melanoma appearing as the primary indexed condition, and to 3 interventions - of which Quality-of-Life Assessment is the first listed.
NCT01644591 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01644591 about?
NCT01644591 is a clinical study titled "Stereotactic Radiosurgery in Treating Patients With Greater Than 3 Melanoma Brain Metastases". This phase II trial studies how well stereotactic radiosurgery works in treating patients with melanoma that has spread to more than 3 places in the brain. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause ...
What is the current status of trial NCT01644591?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2012-08-02. Estimated completion is 2026-08-31.
What conditions does trial NCT01644591 study?
This clinical trial studies the following conditions: Metastatic Melanoma, Metastatic Malignant Neoplasm in the Brain, Clinical Stage IV Cutaneous Melanoma AJCC v8, Pathologic Stage IV Cutaneous Melanoma AJCC v8.
What interventions are being tested in trial NCT01644591?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Stereotactic Radiosurgery (RADIATION).
Who is sponsoring clinical trial NCT01644591?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01644591 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 Metastatic Melanoma
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 NCT01644591's enrollment target sits among peer trials
49 40th of 91 higher than 52 of 91 other Metastatic Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Melanoma 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
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