S0344 Intralesional Resection in Treating Patients With Chondrosarcoma of the Bone

This study has been completed.
Sponsor:
Collaborators:
American College of Surgeons
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00096213
First received: November 9, 2004
Last updated: January 13, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Sarcoma
Procedure: conventional surgery
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Surgical Trial Of Intralesional Resection Of Low-Grade Intracompartmental Chondrosarcoma Of Bone

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Probability of local complications [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Probability of local recurrence and development of metastatic disease [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Impact of musculoskeletal tumor reconstruction on functional status [ Time Frame: two years ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: December 2004
Study Completion Date: August 2009
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
surgery
intralesional resection
Procedure: conventional surgery
surgery

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00096213

Locations
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045
United States, Florida
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0232
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
United States, New Mexico
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States, 87131-5636
United States, Ohio
Akron City Hospital
Akron, Ohio, United States, 44309-2090
United States, Oregon
Oregon Health & Science University Cancer Institute
Portland, Oregon, United States, 97239-3098
United States, Texas
Presbyterian Hospital of Dallas
Dallas, Texas, United States, 75231
United States, Utah
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
United States, Washington
St. Joseph Cancer Center
Bellingham, Washington, United States, 98225
Olympic Hematology and Oncology
Bremerton, Washington, United States, 98310
Skagit Valley Hospital Cancer Care Center
Mt. Vernon, Washington, United States, 98273
Harborview Medical Center
Seattle, Washington, United States, 98104
Minor and James Medical, PLLC
Seattle, Washington, United States, 98104
Group Health Central Hospital
Seattle, Washington, United States, 98112
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98104
Polyclinic First Hill
Seattle, Washington, United States, 98122
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98122-4307
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
North Puget Oncology at United General Hospital
Sedro-Wooley, Washington, United States, 98284
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801-2028
Sponsors and Collaborators
Southwest Oncology Group
American College of Surgeons
Investigators
Study Chair: R. Lor Randall, MD, FACS University of Utah
Study Chair: Janet S. Biermann, MD University of Michigan Cancer Center
Study Chair: Edward Cheng, MD Masonic Cancer Center, University of Minnesota
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00096213     History of Changes
Other Study ID Numbers: CDR0000390349, U10CA032102, S0344, ACOSOG-S0344
Study First Received: November 9, 2004
Last Updated: January 13, 2012
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
chondrosarcoma

Additional relevant MeSH terms:
Chondrosarcoma
Sarcoma
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on July 22, 2014