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| Sponsored by: |
European Organization for Research and Treatment of Cancer |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00030680 |
Purpose
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 |
| MedlinePlus related topics: | Cancer |
| 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.
Eligibility
| 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:
Contacts and Locations| 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 | |||||
| European Organization for Research and Treatment of Cancer |
| Investigator: | R. B. Keus, MD | Arnhems Radiotherapeutisch Instituut |
| Investigator: | Thomas Schnabel, MD | Klinikum der Stadt Ludwigshafen am Rhein |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000069188, EORTC-62991, EORTC-22998 |
| First Received: | February 14, 2002 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00030680 |
| Health Authority: | United States: Federal Government |
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