S0344 Intralesional Resection in Treating Patients With Chondrosarcoma of the Bone

Study Overview
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Brief Summary
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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 well intralesional resection works in treating patients with low-grade chondrosarcoma of the bone.

Detailed Description
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OBJECTIVES: Determine the probability of local complications (e.g., fracture, nerve palsy, deep venous thrombosis, unexpected rehospitalization, unanticipated reoperation, or death within 2 years) in patients with suspected low-grade intracompartmental chondrosarcoma of the bone undergoing intralesional resection. Determine the 5-year probability of local recurrence and development of metastatic disease in patients undergoing this procedure. Determine the impact of musculoskeletal tumor reconstruction on the functional status of patients undergoing this procedure. OUTLINE: This is a multicenter study. Patients undergo intralesional resection (curettage with high-speed burr). Patients then receive local adjuvant treatment comprising liquid nitrogen, phenol, alcohol, or argon beam to the excision site. The bone cavity is then filled with either polymethyacrylate cement or a bone graft (allograft or homograft). Patients may also have a metal plate installed at the wound site. Patients are followed every 3 months for 1 year and then every 6 months for 4 years. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 30-60 months.

Official Title
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A Phase II Surgical Trial Of Intralesional Resection Of Low-Grade Intracompartmental Chondrosarcoma Of Bone

Conditions
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Sarcoma

Intervention / Treatment
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* Procedure: conventional surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: surgery<br>intralesional resection | Procedure: conventional surgery<br>* surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probability of local complications |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probability of local recurrence and development of metastatic disease |  | 5 years | 
| Impact of musculoskeletal tumor reconstruction on functional status |  | two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chondrosarcoma