Stereotactic Radiosurgery in Treating Patients With Greater Than 3 Melanoma Brain Metastases (NCT01644591) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Stereotactic Radiosurgery in Treating Patients With Greater Than 3 Melanoma Brain Metastases
United States49 participantsStarted 2012-08-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 canc…