S0344 Intralesional Resection in Treating Patients With Chondrosarcoma of the Bone

Phase 2

Completed

• Conditions: Sarcoma

• Registration Number: NCT00096213
• Lead Sponsor: SWOG Cancer Research Network

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.

Study Timeline

• Study First Submitted QC: 2004-11-08
• Study First Submitted: 2004-11-09
• Study First Posted: 2004-11-09
• Study Start: 2004-12
• Primary Completion: 2006-04
• Study Completion: 2009-08
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-13
• Last Update Posted: 2012-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Probability of local complications	two years

Secondary Outcome Measures

Name	Time	Method
Probability of local recurrence and development of metastatic disease	5 years
Impact of musculoskeletal tumor reconstruction on functional status	two years

Trial Locations

Locations (23)

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

University of Colorado Cancer Center at University of Colorado Health Sciences Center; 🇺🇸 Aurora, Colorado, United States

University of Florida Shands Cancer Center; 🇺🇸 Gainesville, Florida, United States

University of Michigan Comprehensive Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States

William Beaumont Hospital - Royal Oak Campus; 🇺🇸 Royal Oak, Michigan, United States

University of New Mexico Cancer Research and Treatment Center; 🇺🇸 Albuquerque, New Mexico, United States

Akron City Hospital; 🇺🇸 Akron, Ohio, United States

Oregon Health & Science University Cancer Institute; 🇺🇸 Portland, Oregon, United States

Presbyterian Hospital of Dallas; 🇺🇸 Dallas, Texas, United States

Huntsman Cancer Institute at University of Utah; 🇺🇸 Salt Lake City, Utah, United States

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