Status:
COMPLETED
S0344 Intralesional Resection in Treating Patients With Chondrosarcoma of the Bone
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
American College of Surgeons
Conditions:
Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Intralesional resection is a less invasive type of surgery for chondrosarcoma of the bone and may have fewer side effects and improve recovery. PURPOSE: This phase II trial is studying how...
Detailed Description
OBJECTIVES: * Determine the probability of local complications (e.g., fracture, nerve palsy, deep venous thrombosis, unexpected rehospitalization, unanticipated reoperation, or death within 2 years) ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Suspected low-grade intracompartmental chondrosarcoma, as defined by the following criteria:
- Resorption of prior calcifications (indicated by a change in radiographic appearance over time) AND/OR meets at least 2, but no more than 4, of the following criteria:
- Permeative appearance of medullary bone, defined as presence of tumor around 3 sides of a trabecula of normal bone
- Endosteal scalloping, defined as \> 50% of adjacent cortical thickness
- Cortical thickening beyond the thickness of adjacent normal bone
- Bone expansion, defined as a circumferential increase in diameter of the bone beyond the adjacent normal bone
- Positive (i.e., increased uptake or "hot") bone scan
- No cortical disruption and/or soft tissue mass by radiography and CT scan (3 mm cuts are optimal) or MRI
- No presumptive axial (spinal) involvement
- No multifocal disease by bone scan
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- Not specified
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- Not specified
- Renal
- Not specified
- Other
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No prior biologic therapy for this tumor
- Chemotherapy
- No prior chemotherapy for this tumor
- Endocrine therapy
- Not specified
- Radiotherapy
- No prior radiotherapy for this tumor
- Surgery
- No prior surgery for this tumor except biopsy\*
- No concurrent intramedullary fixation NOTE: \*Biopsy is not required
- Other
- No prior investigational anticancer agents for this tumor
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00096213
Start Date
December 1 2004
End Date
August 1 2009
Last Update
January 18 2012
Active Locations (23)
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1
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
2
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045
3
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0232
4
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942