Sarcoma Clinical Trial
Official title:
A Phase II Surgical Trial Of Intralesional Resection Of Low-Grade Intracompartmental Chondrosarcoma Of Bone
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.
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.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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