MedPath

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.

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
NameTimeMethod
Local control as assessed by MRI at 3 years
Secondary Outcome Measures
NameTimeMethod
Toxicity as assessed by CTC 2.0
Response as assessed by MRI

Trial Locations

Locations (21)

Cliniques Universitaires Saint-Luc

🇧🇪

Brussels, Belgium

Leiden University Medical Center

🇳🇱

Leiden, Netherlands

Daniel Den Hoed Cancer Center at Erasmus Medical Center

🇳🇱

Rotterdam, Netherlands

Maastro Clinic - Locatie Maastricht

🇳🇱

Maastricht, Netherlands

University Medical Center Groningen

🇳🇱

Groningen, Netherlands

Centre Leon Berard

🇫🇷

Lyon, France

Cookridge Hospital

🇬🇧

Leeds, England, United Kingdom

Christie Hospital

🇬🇧

Manchester, England, United Kingdom

Universitair Ziekenhuis Antwerpen

🇧🇪

Edegem, Belgium

Arnhems Radiotherapeutisch Instituut

🇳🇱

Arnhem, Netherlands

Institut Bergonie

🇫🇷

Bordeaux, France

CHU de la Timone

🇫🇷

Marseille, France

Southwest German Cancer Center at Eberhard-Karls-University

🇩🇪

Tuebingen, Germany

Dr. Bernard Verbeeten Instituut

🇳🇱

Tilburg, Netherlands

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

🇵🇱

Warsaw, Poland

Mount Vernon Cancer Centre at Mount Vernon Hospital

🇬🇧

Northwood, England, United Kingdom

Centre Hospitalier Universitaire Vaudois

🇨🇭

Lausanne, Switzerland

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

🇬🇧

Birmingham, England, United Kingdom

Nottingham City Hospital NHS Trust

🇬🇧

Nottingham, England, United Kingdom

Cancer Research Centre at Weston Park Hospital

🇬🇧

Sheffield, England, United Kingdom

Royal Marsden - Surrey

🇬🇧

Sutton, England, United Kingdom

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