Radiation Therapy in Treating Patients With Aggressive Fibromatoses

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Pilot Study Of Moderate Dose Radiotherapy For Inoperable Aggressive Fibromatoses

Conditions
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Desmoid Tumor

Intervention / Treatment
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* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local control as assessed by MRI at 3 years |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity as assessed by CTC 2.0 |  |  | 
| Response as assessed by MRI |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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desmoid tumor