Melatonin and Radiation Therapy in Treating Patients With Brain Metastases
- Conditions
- Metastatic CancerRadiation ToxicityUnspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT00031967
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as melatonin may make tumor cells more sensitive to radiation therapy and may protect normal cells from the side effects of radiation therapy.
PURPOSE: Randomized phase II trial to determine the effectiveness of combining melatonin with radiation therapy in treating patients who have brain metastases.
- Detailed Description
OBJECTIVES:
* Determine the effect of melatonin, used as radiosensitization/radioprotection, on overall survival and clinical deterioration in patients with brain metastases who are undergoing radiotherapy.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to planned chemotherapy after whole brain irradiation (yes vs no). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients undergo whole brain irradiation once daily 5 days a week for 2 weeks. Patients receive oral melatonin once daily every morning.
* Arm II: Patients undergo whole brain irradiation as in arm I. Patients receive oral melatonin once daily every evening.
All patients continue on melatonin for 6 months in the absence of disease progression or unacceptable toxicity.
Patients are followed at months 6 and 12 from start of radiotherapy and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 128 patients (64 per treatment arm) will be accrued for this study within 5 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (234)
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Comprehensive Cancer Institute of Huntsville
🇺🇸Huntsville, Alabama, United States
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
Alabama Oncology, LLC
🇺🇸Montgomery, Alabama, United States
DCH Cancer Treatment Center
🇺🇸Tuscaloosa, Alabama, United States
Foundation for Cancer Research and Education
🇺🇸Phoenix, Arizona, United States
Mount Diablo Medical Center
🇺🇸Concord, California, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Saint Agnes Cancer Center
🇺🇸Fresno, California, United States
California Cancer Center
🇺🇸Fresno, California, United States
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