Spots Global Cancer Trial Database for Evaluation of Lucanthone to Whole Brain Radiation Therapy in Patients With Brain Metastases From Non-Small Cell Lung Cancer
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Trial Identification
Brief Title: Evaluation of Lucanthone to Whole Brain Radiation Therapy in Patients With Brain Metastases From Non-Small Cell Lung Cancer
Official Title: Phase II Trial Evaluating the Addition of Lucanthone to Whole Brain Radiation Therapy in Patients With Brain Metastases From Non-Small Cell Lung Cancer
Study ID: NCT02014545
Study Description
Brief Summary: This is a randomized, double blind placebo controlled study to evaluate safety and efficacy of lucanthone administered as an adjunct to patients receiving whole brain radiation therapy (WBRT) as primary treatment for brain metastases secondary to non-small cell lung cancer.
Detailed Description: Eligible patients for this trial will be randomized to lucanthone or placebo in a ratio of 1:1. The treatment will consist of WBRT given in a dose of 30 Gy in ten fractions. Lucanthone/placebo will be given as an adjunct to the WBRT on days that WBRT is administered. Tumor assessments will be done with a brain MRI. Radiological assessments on the tumor will be made periodically throughout the study and will be discontinued at the time of tumor progression. Safety will be evaluated for one year during the study period and survival data will be collected thereafter.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Comprehensive Cancer Center of Wake Forest University, Winston-Salem, North Carolina, United States
Contact Details
Name: Stefan C. Grant, MD, JD
Affiliation: Wake Forest University Health Sciences
Role: PRINCIPAL_INVESTIGATOR
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