Radiation Therapy in Treating Patients With Aggressive Fibromatoses
NCT ID: NCT00030680
Last Updated: 2013-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
44 participants
INTERVENTIONAL
2001-11-30
2012-03-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of radiation therapy in treating patients who have aggressive fibromatoses.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
* Progressive disease defined as at least 20% increase in tumor size on 2 MRI scans within 1 year after any prior therapy except radiotherapy OR
* Incompletely resected tumor with gross residual disease not suitable for further surgery
* Resected within the past 3 months
* Lesions must be suitable for radiotherapy
* No bulky intra-abdominal disease in close relation to small bowel
* Measurable disease
PATIENT CHARACTERISTICS:
Age:
* 16 and over
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* No conditions that would preclude study follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Prior chemotherapy allowed
* No concurrent chemotherapy
Endocrine therapy:
* Prior endocrine therapy allowed
* No concurrent endocrine therapy
Radiotherapy:
* See Disease Characteristics
* No prior radiotherapy to indicator lesion
Surgery:
* See Disease Characteristics
* Prior surgery allowed
Other:
* No prior isolated limb perfusion with tumor necrosis factor
* No concurrent isolated limb perfusion with tumor necrosis factor
16 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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R. B. Keus, MD
Role: STUDY_CHAIR
Arnhems Radiotherapeutisch Instituut
Thomas Schnabel, MD
Role: STUDY_CHAIR
Klinikum der Stadt Ludwigshafen am Rhein
Locations
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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
Tübingen, , 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
Countries
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Other Identifiers
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EORTC-62991
Identifier Type: -
Identifier Source: secondary_id
EORTC-22998
Identifier Type: -
Identifier Source: secondary_id
EORTC-62991-22998
Identifier Type: -
Identifier Source: org_study_id