NCT00096213

S0344 Intralesional Resection in Treating Patients With Chondrosarcoma of the Bone

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sarcoma

Interventions

Type	Name	Description
PROCEDURE	conventional surgery	surgery

Timeline

• Start date: 2004-12-01
• Primary completion: 2006-04-01
• Completion: 2009-08-01
• First posted: 2004-11-09
• Last updated: 2012-01-18

Locations

23 sites across 1 country: United States