Phase II Pilot Study Of Moderate Dose Radiotherapy For Inoperable Aggressive Fibromatoses
16 Years
N/A
Both
Desmoid Tumor
Trial Information
Phase II Pilot Study Of Moderate Dose Radiotherapy For Inoperable 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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Local control as assessed by MRI at 3 years
Safety Issue:
No
Principal Investigator
R. B. Keus, MD
Investigator Affiliation:
Arnhems Radiotherapeutisch Instituut
Authority:
United States: Federal Government
Study ID:
CDR0000069188
NCT ID:
NCT00030680
Start Date:
November 2001
Completion Date:
Related Keywords:
- Desmoid Tumor
- desmoid tumor
- Fibroma
- Fibromatosis, Aggressive
Name | Location |
|---|
