Sarcoma
Conditions
Keywords
chondrosarcoma
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 well intralesional resection works in treating patients with low-grade chondrosarcoma of the bone.
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) 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.
Interventions
PROCEDUREconventional surgery
surgery
Sponsors
National Cancer Institute (NCI)
American College of Surgeons
SWOG Cancer Research Network
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Probability of local complications | two years |
Secondary
| Measure | Time frame |
|---|---|
| Probability of local recurrence and development of metastatic disease | 5 years |
| Impact of musculoskeletal tumor reconstruction on functional status | two years |
Countries
United States
Outcome results
None listed