Radiation Therapy in Treating Patients With Aggressive Fibromatoses

Phase 2

Completed

• Conditions: Desmoid Tumor

• Registration Number: NCT00030680
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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 5.5 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 Timeline

• Study Start: 2001-11
• Study First Submitted: 2002-02-14
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-26
• Last Update Posted: 2013-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Local control as assessed by MRI at 3 years

Secondary Outcome Measures

Name	Time	Method
Toxicity as assessed by CTC 2.0
Response as assessed by MRI

Trial Locations

Locations (21)

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels, Belgium

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

Institut Bergonie; 🇫🇷 Bordeaux, France

Centre Leon Berard; 🇫🇷 Lyon, France

CHU de la Timone; 🇫🇷 Marseille, France

Southwest German Cancer Center at Eberhard-Karls-University; 🇩🇪 Tuebingen, Germany

Arnhems Radiotherapeutisch Instituut; 🇳🇱 Arnhem, Netherlands

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

Maastro Clinic - Locatie Maastricht; 🇳🇱 Maastricht, Netherlands

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