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Home > "R" Clinical Trials Conditions > Radiation Therapy in Treating Patients With Aggressive Fibromatoses  Radiation Therapy in Treating Patients With Aggressive Fibromatoses
Radiation Therapy in Treating Patients With Aggressive Fibromatoses
For Condition: desmoid tumor
Status: Recruiting
Sponsor(s): EORTC Soft Tissue and Bone Sarcoma Cooperative Group , EORTC Radiotherapy Cooperative Group
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: 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 - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ThomasSchnabel, , Klinikum der Stadt Ludwigshafen am Rhein
Radiotherapeutisch Instituut Limburg-Maastricht *Recruiting*
Maastricht, , NL-6229 ET
Netherlands
Recruiting Contact Person 31-43-387-4461
Arnhems Radiotherapeutisch Instituut *Recruiting*
ARNHEM, , 6815 AD
Netherlands
Recruiting Contact Person 31-85-371-2470
Weston Park Hospital *Recruiting*
Sheffield, England, S1O 2SJ
United Kingdom
Recruiting Contact Person 44-114-226-5000
Dr. Bernard Verbeeten Instituut *Recruiting*
Tilburg, , 5042 SB
Netherlands
Recruiting Contact Person 31-13-594-7777
Leiden University Medical Center *Recruiting*
Leiden, , 2300 RC
Netherlands
Recruiting Contact Person 31-71-526-911
Universitair Ziekenhuis Antwerpen *Recruiting*
Edegem, , B-2650
Belgium
Recruiting Contact Person 32-03-821-33-75
Centre Leon Berard *Recruiting*
Lyon, , 69008
France
Recruiting Contact Person 33-478-782-828
Daniel Den Hoed Cancer Center at Erasmus Medical Center *Recruiting*
Rotterdam, , 3008 AE
Netherlands
Recruiting Contact Person 31-10-439-1911
Centre Hospitalier Universitaire Vaudois *Recruiting*
Lausanne, , CH-1011
Switzerland
Recruiting Contact Person 41-21-314-1111
Eberhard Karls Universitaet *Recruiting*
Tuebingen, , D-72076
Germany
Recruiting Contact Person 49-7071-292-711
Christie Hospital N.H.S. Trust *Recruiting*
Manchester, England, M20 4BX
United Kingdom
Recruiting Contact Person 44-161-446-3000
Institut Bergonie *Recruiting*
Bordeaux, , 33076
France
Recruiting Contact Person 33-556-333-333
Cliniques Universitaires Saint-Luc *Recruiting*
Brussels, , 1200
Belgium
Recruiting Contact Person 32-2-764-1111
Additional Information:
Study ID Numbers: CDR0000069188; EORTC-22998,EORTC-62991
Study Start Date:
Record last reviewed: June 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030680
Other Desmoid Tumor Studies:
1. Sulindac and Tamoxifen in Treating Patients With Desmoid Tumor
2. Vinblastine and Methotrexate in Treating Children With Desmoid Tumors
3. Radiation Therapy in Treating Patients With Aggressive Fibromatoses
Related Studies:
Other desmoid tumor Clinical Trials
Other Clinical Trials
Other Rotterdam Clinical Trials
Radiation Therapy in Treating Patients With Aggressive Fibromatoses
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