Viewing Study NCT00030680



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Last Modification Date: 2024-10-26 @ 9:07 AM
Study NCT ID: NCT00030680
Status: COMPLETED
Last Update Posted: 2013-08-27
First Post: 2002-02-14

Brief Title: Radiation Therapy in Treating Patients With Aggressive Fibromatoses
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Organization: European Organisation for Research and Treatment of Cancer - EORTC

Study Overview

Official Title: Phase II Pilot Study Of Moderate Dose Radiotherapy For Inoperable Aggressive Fibromatoses
Status: COMPLETED
Status Verified Date: 2013-08
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

PURPOSE Phase II trial to study the effectiveness of radiation therapy in treating patients who have aggressive fibromatoses
Detailed Description: OBJECTIVES

Determine the efficacy of moderate-dose radiotherapy in terms of local control in patients with aggressive fibromatoses
Determine the acute and late side-effects of this regimen in these patients

OUTLINE This is a multicenter study

Patients receive radiotherapy 5 days a week for 55 weeks for a total of 56 Gy in 28 fractions

Patients are followed every 3 months for 2 years and then every 6 months thereafter

PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 3 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
EORTC-22998 None None None
EORTC-62991 None None None