A Pilot/Phase II Study of Gamma Knife Radiosurgery for Brain Metastases Using 3Tesla MRI and Rational Dose Selection

Breast Cancer Clinical Trial

Official title:

A Pilot/Phase II Study of Gamma Knife Radiosurgery for Brain Metastases Using 3Tesla MRI and Rational Dose Selection

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02005614
• Other study ID #: 1306012291
• Status: Terminated
• Phase: N/A
• Start date: November 2013
• Est. completion date: August 2018

Study information

• Verified date: June 2019
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: August 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must have histologically or cytologically confirmed malignancy (not leukemia or lymphoma). There must be metastatic brain disease apparent on magnetic resonance imaging which offers a medical indication for brain radiation. - Age > 18

• Karnofsky Performance Status > 70

• MRI performed within 4 weeks of trial enrollment

• Medical oncologist or consenting physician verifies that chemotherapy options exist after treatment with intracranial therapy, and that chemotherapy is planned to initiate after completion of radiation. Or, survival as estimated by the medical oncologist or enrolling physician is > 3 months.

Exclusion Criteria:

• Extremely radiosensitive tumor (lymphoma, leukemia)

• Radiosensitivity syndrome (scleroderma, dermatomyositis, other genetic syndrome that predisposes to adverse radiotherapy complications)

• Evidence of leptomeningeal dissemination

• Resection of brain metastases, otherwise untreated with radiation for those brain lesions (presenting for postoperative consolidative radiotherapy)

• Presence of a medical device (pacemaker, stent) or allergy that precludes contrast enhanced MRI

• Patient is unable to tolerate placement of a stereotactic headframe

• Pregnancy

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Breast Cancer
• Carcinoma, Renal Cell
• Colorectal Cancer
• Colorectal Neoplasms
• Gastrointestinal Cancers
• Gastrointestinal Neoplasms
• Lung Cancer
• Melanoma
• Neoplasm Metastasis
• Renal Cell Carcinoma
• Sarcoma

Intervention

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.

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Local Control Over time (RECIST Criteria)	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	Up to 2 years