Viewing Study NCT00003911



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Last Modification Date: 2024-10-26 @ 9:04 AM
Study NCT ID: NCT00003911
Status: TERMINATED
Last Update Posted: 2013-01-31
First Post: 1999-11-01

Brief Title: S9903 Whole Brain Radiotherapy Followed By Stereotactic Radiosurgery for Limited Malignant Melanoma Brain Metastases
Sponsor: SWOG Cancer Research Network
Organization: SWOG Cancer Research Network

Study Overview

Official Title: A Phase II Pilot Study of Stereotactic Radiosurgery for Limited Malignant Melanoma Brain Metastases
Status: TERMINATED
Status Verified Date: 2013-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Poor accrual
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 Stereotactic radiosurgery may kill more tumor cells

PURPOSE Phase II trial to study the effectiveness of radiation therapy followed by stereotactic radiosurgery in treating patients who have brain metastases from malignant melanoma
Detailed Description: OBJECTIVES I Estimate the 6 month intracranial progression rate and 6 month overall survival rate in patients with limited brain metastases from malignant melanoma undergoing whole brain radiotherapy followed by stereotactic radiosurgery boost II Evaluate the qualitative and quantitative toxic effects of this regimen in these patients

OUTLINE Patients undergo whole brain radiotherapy 5 days a week for 3 weeks followed 3-5 weeks later by stereotactic radiosurgery Patients are followed every 3 months until death

PROJECTED ACCRUAL A total of 60 patients will be accrued for this study within 2 years

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
U10CA032102 NIH SWOG httpsreporternihgovquickSearchU10CA032102
S9903 OTHER None None