A Phase 2 interventional study of therapeutic melatonin and radiation therapy in Metastatic Cancer, Radiation Toxicity and Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Radiation Therapy Oncology Group. Completed at 234 sites in 2 countries. Open to participants aged 0 Years to 120 Years. Per ClinicalTrials.gov, last updated 2020-10-22.
Sponsored by Radiation Therapy Oncology Group · Phase 2, Interventional, and Treatment
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.
OBJECTIVES:
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.
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.
1,959 studies on the registry are indexed under Brain Neoplasms; 515 are open to participants now.
Browse Brain Neoplasms studies →Radiation Therapy Oncology Group is the lead sponsor of 154 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumor with brain metastasis
RPA class II with any of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Showing the first 100 of 234 sites across 2 countries.
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Radiation Therapy Oncology Group