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| ID | Type | Description | Link |
|---|---|---|---|
| EORTC-62991 | |||
| EORTC-22998 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiation therapy | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Local control as assessed by MRI at 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity as assessed by CTC 2.0 | ||
| Response as assessed by MRI |
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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
Measurable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| R. B. Keus, MD | Arnhems Radiotherapeutisch Instituut | Study Chair |
| Thomas Schnabel, MD | Klinikum der Stadt Ludwigshafen am Rhein | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques Universitaires Saint-Luc | Brussels | 1200 | Belgium | |||
| Universitair Ziekenhuis Antwerpen |
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| Edegem |
| B-2650 |
| Belgium |
| Institut Bergonie | Bordeaux | 33076 | France |
| Centre Leon Berard | Lyon | 69008 | France |
| CHU de la Timone | Marseille | 13385 | France |
| Southwest German Cancer Center at Eberhard-Karls-University | Tübingen | D-72076 | Germany |
| Arnhems Radiotherapeutisch Instituut | Arnhem | 6815 AD | Netherlands |
| University Medical Center Groningen | Groningen | 9700 RB | Netherlands |
| Leiden University Medical Center | Leiden | 2300 RC | Netherlands |
| Maastro Clinic - Locatie Maastricht | Maastricht | NL-6229 ET | Netherlands |
| Daniel Den Hoed Cancer Center at Erasmus Medical Center | Rotterdam | 3008 AE | Netherlands |
| Dr. Bernard Verbeeten Instituut | Tilburg | 5042 SB | Netherlands |
| Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology | Warsaw | 02-781 | Poland |
| Centre Hospitalier Universitaire Vaudois | Lausanne | CH-1011 | Switzerland |
| Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust | Birmingham | England | B15 2TH | United Kingdom |
| Cookridge Hospital | Leeds | England | LS16 6QB | United Kingdom |
| Christie Hospital | Manchester | England | M20 4BX | United Kingdom |
| Mount Vernon Cancer Centre at Mount Vernon Hospital | Northwood | England | HA6 2RN | United Kingdom |
| Nottingham City Hospital NHS Trust | Nottingham | England | NG5 1PB | United Kingdom |
| Cancer Research Centre at Weston Park Hospital | Sheffield | England | S1O 2SJ | United Kingdom |
| Royal Marsden - Surrey | Sutton | England | SM2 5PT | United Kingdom |
| ID | Term |
|---|---|
| D018222 | Desmoid Tumors |
| ID | Term |
|---|---|
| D005350 | Fibroma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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