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Brief Title: Radiation Therapy in Treating Patients With Aggressive Fibromatoses
Official Title: Phase II Pilot Study Of Moderate Dose Radiotherapy For Inoperable Aggressive Fibromatoses
Study ID: NCT00030680
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.
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Daniel Den Hoed Cancer Center at Erasmus Medical Center, Rotterdam, , Netherlands
Dr. Bernard Verbeeten Instituut, Tilburg, , Netherlands
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, , Poland
Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust, Birmingham, England, United Kingdom
Cookridge Hospital, Leeds, England, United Kingdom
Christie Hospital, Manchester, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital, Northwood, 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
Name: R. B. Keus, MD
Affiliation: Arnhems Radiotherapeutisch Instituut
Role: STUDY_CHAIR
Name: Thomas Schnabel, MD
Affiliation: Klinikum der Stadt Ludwigshafen am Rhein
Role: STUDY_CHAIR