Radiation Therapy in Treating Patients With Aggressive Fibromatoses

European Organisation for Research and Treatment of Cancer - EORTC44 enrolled

Overview

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: * 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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Desmoid Tumor

Interventions

radiation therapyRADIATION

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (21)

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Outcomes

Primary Outcomes

Local control as assessed by MRI at 3 years

Secondary Outcomes

Toxicity as assessed by CTC 2.0

Response as assessed by MRI

Data from ClinicalTrials.gov

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