Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Treatment | Closed | 16 and over | Other | CDR0000069188 EORTC-62991, EORTC-22998, NCT00030680 |
Summary
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.
Further Study Information
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 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
Trial Lead Organizations/Sponsors
European Organization for Research and Treatment of Cancer
| R. B. Keus |  |
| Thomas Schnabel | |
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00030680
Information obtained from ClinicalTrials.gov on December 21, 2011
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