Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031967
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2002-03-08
Brief Title:
Melatonin and Radiation Therapy in Treating Patients With Brain Metastases
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Randomized Phase II Study of AM and PM Melatonin for Brain Metastasis in RPA Class II Patients
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 radiosensitizationradioprotection 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
Determine the effect of melatonin used as radiosensitizationradioprotection 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000069245 | None | None | None |