S0344 Intralesional Resection in Treating Patients With Chondrosarcoma of the Bone

Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00096213
• Other study ID #: CDR0000390349
• Secondary ID: U10CA032102S0344
• Status: Completed
• Phase: Phase 2
• First received: November 9, 2004
• Last updated: January 13, 2012
• Start date: December 2004
• Est. completion date: August 2009

Study information

• Verified date: January 2012
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2009
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chondrosarcoma
• Sarcoma

Intervention

Procedure:
• conventional surgery
surgery

Locations

Country	Name	City	State
United States	Akron City Hospital	Akron	Ohio
United States	University of New Mexico Cancer Research and Treatment Center	Albuquerque	New Mexico
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	University of Colorado Cancer Center at University of Colorado Health Sciences Center	Aurora	Colorado
United States	St. Joseph Cancer Center	Bellingham	Washington
United States	Olympic Hematology and Oncology	Bremerton	Washington
United States	Presbyterian Hospital of Dallas	Dallas	Texas
United States	University of Florida Shands Cancer Center	Gainesville	Florida
United States	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Skagit Valley Hospital Cancer Care Center	Mt. Vernon	Washington
United States	Oregon Health & Science University Cancer Institute	Portland	Oregon
United States	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan
United States	Huntsman Cancer Institute at University of Utah	Salt Lake City	Utah
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Group Health Central Hospital	Seattle	Washington
United States	Harborview Medical Center	Seattle	Washington
United States	Minor and James Medical, PLLC	Seattle	Washington
United States	Polyclinic First Hill	Seattle	Washington
United States	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington
United States	University Cancer Center at University of Washington Medical Center	Seattle	Washington
United States	North Puget Oncology at United General Hospital	Sedro-Wooley	Washington
United States	Cancer Care Northwest - Spokane South	Spokane	Washington
United States	Wenatchee Valley Medical Center	Wenatchee	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Southwest Oncology Group	American College of Surgeons, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probability of local complications		two years	No
Secondary	Probability of local recurrence and development of metastatic disease		5 years	No
Secondary	Impact of musculoskeletal tumor reconstruction on functional status		two years	No