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Sponsored by: |
European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00030680 |
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.
Condition | Intervention | Phase |
---|---|---|
Desmoid Tumor |
Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Pilot Study Of Moderate Dose Radiotherapy For Inoperable Aggressive Fibromatoses |
Estimated Enrollment: | 40 |
Study Start Date: | November 2001 |
OBJECTIVES:
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.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed aggressive fibromatoses arising in any site
Primary, recurrent, or progressive disease that is inoperable or requires a major operation resulting in a large functional or cosmetic deficit or mutilation
Incompletely resected tumor with gross residual disease not suitable for further surgery
Lesions must be suitable for radiotherapy
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Belgium | |
Cliniques Universitaires Saint-Luc | |
Brussels, Belgium, 1200 | |
Universitair Ziekenhuis Antwerpen | |
Edegem, Belgium, B-2650 | |
France | |
Centre Leon Berard | |
Lyon, France, 69008 | |
CHU de la Timone | |
Marseille, France, 13385 | |
Institut Bergonie | |
Bordeaux, France, 33076 | |
Germany | |
Southwest German Cancer Center at Eberhard-Karls-University | |
Tuebingen, Germany, D-72076 | |
Netherlands | |
Arnhems Radiotherapeutisch Instituut | |
Arnhem, Netherlands, 6815 AD | |
Daniel Den Hoed Cancer Center at Erasmus Medical Center | |
Rotterdam, Netherlands, 3008 AE | |
Dr. Bernard Verbeeten Instituut | |
Tilburg, Netherlands, 5042 SB | |
Leiden University Medical Center | |
Leiden, Netherlands, 2300 RC | |
Maastro Clinic - Locatie Maastricht | |
Maastricht, Netherlands, NL-6229 ET | |
University Medical Center Groningen | |
Groningen, Netherlands, 9700 RB | |
Poland | |
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology | |
Warsaw, Poland, 02-781 | |
Switzerland | |
Centre Hospitalier Universitaire Vaudois | |
Lausanne, Switzerland, CH-1011 | |
United Kingdom, England | |
Cancer Research Centre at Weston Park Hospital | |
Sheffield, England, United Kingdom, S1O 2SJ | |
Christie Hospital | |
Manchester, England, United Kingdom, M20 4BX | |
Royal Marsden - Surrey | |
Sutton, England, United Kingdom, SM2 5PT | |
Mount Vernon Cancer Centre at Mount Vernon Hospital | |
Northwood, England, United Kingdom, HA6 2RN | |
Nottingham City Hospital NHS Trust | |
Nottingham, England, United Kingdom, NG5 1PB | |
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust | |
Birmingham, England, United Kingdom, B15 2TH | |
Cookridge Hospital | |
Leeds, England, United Kingdom, LS16 6QB |
Investigator: | R. B. Keus, MD | Arnhems Radiotherapeutisch Instituut |
Investigator: | Thomas Schnabel, MD | Klinikum der Stadt Ludwigshafen am Rhein |
Study ID Numbers: | CDR0000069188, EORTC-62991, EORTC-22998 |
Study First Received: | February 14, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00030680 |
Health Authority: | United States: Federal Government |
desmoid tumor |
Neoplasms, Connective and Soft Tissue Fibroma Fibromatosis, Aggressive Desmoid tumor |
Fibromatosis Aggressive fibromatosis Aggression |
Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Fibrous Tissue |