Melatonin and Radiation Therapy in Treating Patients With Brain Metastases

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title: A Randomized Phase II Study of A.M. and P.M. Melatonin for Brain Metastasis in RPA Class II Patients

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis
• Radiation Toxicity
• Unspecified Adult Solid Tumor, Protocol Specific

• NCT number: NCT00031967
• Study type: Interventional
• Source: Radiation Therapy Oncology Group
• Status: Completed
• Phase: Phase 2
• Start date: May 2002