Radiation Therapy in Treating Patients With Aggressive Fibromatoses

European Organisation for Research and Treatment of Cancer (EORTC)

Status and phase: Completed; Phase 2

Conditions: Desmoid Tumor

Treatments: Radiation: radiation therapy

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00030680

EORTC-62991-22998

EORTC-62991

EORTC-22998

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 44 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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