Clinical trial · Interventional
Stereotactic Radiosurgery in Treating Patients With Greater Than 3 Melanoma Brain Metastases
A Phase II Trial to Determine Local Control and Neurocognitive Preservation After Initial Treatment With Stereotactic Radiosurgery (SRS) for Patients With >3 Melanoma Brain Metastases
NCT01644591CI-TRIAL-00123123active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clinical Stage IV Cutaneous Melanoma AJCC v8 | — | UNRESOLVED | — |
| Metastatic Malignant Neoplasm in the Brain | — | UNRESOLVED | — |
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
| Pathologic Stage IV Cutaneous Melanoma AJCC v8 | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Stereotactic Radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (SRS)
- description
- Patients undergo SRS on day 1.
- interventionNames
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- Radiation: Stereotactic Radiosurgery
Primary outcomes (2)
- measure
- Time to progression
- timeFrame
- Up to 12 months
- description
- 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.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All patients with histologic proof of malignant melanoma. Histologic confirmation may be from the primary tumor site, or from another metastatic site (systemic lymph node, etc). Cytology-alone is not an acceptable method of diagnosis * Greater than 3 presumed melanoma brain metastases on contrast-enhanced brain MRI scan obtained no greater than 4 weeks prior to study registration * Patients must sign informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital * Patients must have Karnofsky performance status (KPS) \>= 70 * Patients must be eligible to have all lesions treated as determined by the study radiation oncologist * Creatinine clearance \> 30 ml/min * Platelets \> 50,000 * Patients should have normal coagulation (international normalized ratio \[INR\] \< 1.3) and be able to withhold anticoagulation/antiplatelet medications a minimum of 24 hours prior to radiosurgery treatment (or until INR normalizes), on the day of treatment and 24 hours after radiosurgery treatment has concluded * Patients can be undergoing concurrent systemic therapy, such as temozolomide, at the discretion of their treating oncologist Exclusion Criteria: * Patients are excluded if they have been treated with whole brain radiotherapy within the prior 3 months * Patients are excluded if they have a history of metastatic cancer in addition to melanoma or a history of uncontrolled non-metastatic cancer. Patients with localized squamous cell carcinoma and/or basal cell carcinoma are not excluded * Patients are excluded if there is radiographic or cerebrospinal fluid (CSF) evidence of leptomeningeal disease * Female patients of childbearing age are excluded if they are pregnant as determined with a serum beta HCG no greater than 14 days prior to study registration, or breast-feeding. (The exclusion is made because gadolinium may be teratogenic in pregnancy) * Patients are excluded if there is any history of gadolinium allergy * Patients are excluded if they are unable to obtain a magnetic resonance imaging (MRI) scan for any other reason
References
Publications (0)
Data not yet available
No reference posted for this study.