A Pilot/Phase II Study of Gamma Knife Radiosurgery for Brain Metastases Using 3Tesla MRI and Rational Dose Selection
The purpose of this study is to collect prospective data for use as a comparator for future subsequent studies attempting to increase the efficacy or reduce the toxicity of gamma knife radiosurgery.
Renal Cell Carcinoma
Procedure: Gamma Knife Radiosurgery
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot/Phase II Study of Gamma Knife Radiosurgery for Brain Metastases Using 3Tesla MRI and Rational Dose Selection|
- Rate of Local Control Over time (RECIST Criteria) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Response or progression of the radiated lesion will be measured by change in the largest unidimensional measurement.
Additionally, response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee
Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Local control is defined as a lack of progressive disease, as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria of a 20% increase in the longest diameter for a target lesion.
If the lesion grows beyond 20% of the longest diameter of the pre-treatment, but subsequently regresses without further lesion-targeted radiotherapy, it will be assumed that the lesion was treatment related radiation necrosis in analysis
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Experimental: Gamma Knife Radiosurgery
"Rational dose selection" is a concept wherein doses used for stereotactic radiosurgery is selected based on tumor volume, prior irradiation with whole brain radiotherapy, and the relative radioresistance of the tumor (radioresistant = melanoma, renal cell carcinoma, sarcoma; radiosensitive = breast cancer, lung cancer, colorectal cancer, gastrointestinal cancers).
Dose may be altered for lesions in the brainstem, adjacent to the optic nerve, optic chiasm, or motor cortex, or other clinical scenarios as defined by the treating physician. Reason for dose alteration will be recorded at the time of treatment.
For patients with 10+ brain metastases with multimorbidity or difficulty in tolerating a supine position, doses may be modified by the treating physicians for patient comfort.
Procedure: Gamma Knife Radiosurgery
Treatment will be administered on an outpatient basis. No other treatment, investigational or commercial agents or therapies other than those described below may be administered with the intent to treat the patient's brain metastases.
Gamma knife radiosurgery is a one day out-patient procedure. Time from initiation of treatment (premedication and placement of a stereotactic frame) until end of treatment (completion of radiation delivery and removal of stereotactic frame) ranges from 3 to 16 hours.
The aims of this study are to pilot a study to measure local control after "rational dose" selected gamma knife radiosurgery for brain metastases and to measure treatment related toxicity for rational dose selected gamma knife radiosurgery for brain metastases. In addition, the quality of life and neurocognition of patients undergoing gamma knife radiosurgery will be measured using the validated European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-BN20 survey instruments. "Rational dose selection" is a concept wherein doses used for stereotactic radiosurgery is selected based on tumor volume, prior irradiation with whole brain radiotherapy, and the relative radioresistance of the tumor (radioresistant = melanoma, renal cell carcinoma, sarcoma; radiosensitive = breast cancer, lung cancer, colorectal cancer, gastrointestinal cancers).
Eligible patients will have histologically confirmed cancer and MRI evidence of metastatic disease within the brain. Patients will be eligible for the trial if intracranial radiosurgery has been recommended for treatment of brain metastases. Patients will be excluded if they have an extremely radiosensitive tumor (leukemia, lymphoma), a radiosensitivity syndrome, a resection of a brain metastasis, or cannot tolerate the MRI or placement of a stereotactic head frame. All patients must sign informed consent.
Radiation will consist of gamma knife radiosurgery delivered using doses selected based on the concept of "rational dose selection" as summarized above.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02005614
|Contact: James B Yu, MDfirstname.lastname@example.org|
|United States, Connecticut|
|New Haven, Connecticut, United States, 06520|
|Contact: James B Yu, MD 203-785-5703 email@example.com|
|Principal Investigator:||James B Yu, MD||Yale University|