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S0344 Intralesional Resection in Treating Patients With Chondrosarcoma of the Bone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00096213
Recruitment Status : Completed
First Posted : November 9, 2004
Last Update Posted : January 18, 2012
National Cancer Institute (NCI)
American College of Surgeons
Information provided by (Responsible Party):
Southwest Oncology Group

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.

Condition or disease Intervention/treatment Phase
Sarcoma Procedure: conventional surgery Phase 2

Detailed Description:


  • 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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Surgical Trial Of Intralesional Resection Of Low-Grade Intracompartmental Chondrosarcoma Of Bone
Study Start Date : December 2004
Actual Primary Completion Date : April 2006
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
intralesional resection
Procedure: conventional surgery

Primary Outcome Measures :
  1. Probability of local complications [ Time Frame: two years ]

Secondary Outcome Measures :
  1. Probability of local recurrence and development of metastatic disease [ Time Frame: 5 years ]
  2. Impact of musculoskeletal tumor reconstruction on functional status [ Time Frame: two years ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • 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


Biologic therapy

  • No prior biologic therapy for this tumor


  • No prior chemotherapy for this tumor

Endocrine therapy

  • Not specified


  • No prior radiotherapy for this tumor


  • No prior surgery for this tumor except biopsy*
  • No concurrent intramedullary fixation NOTE: *Biopsy is not required


  • No prior investigational anticancer agents for this tumor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00096213

Show Show 23 study locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
American College of Surgeons
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Study Chair: R. Lor Randall, MD, FACS University of Utah
Study Chair: Janet S. Biermann, MD University of Michigan Rogel Cancer Center
Study Chair: Edward Cheng, MD Masonic Cancer Center, University of Minnesota
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Responsible Party: Southwest Oncology Group Identifier: NCT00096213    
Other Study ID Numbers: CDR0000390349
U10CA032102 ( U.S. NIH Grant/Contract )
S0344 ( Other Identifier: SWOG )
ACOSOG-S0344 ( Other Identifier: ACOSOG )
First Posted: November 9, 2004    Key Record Dates
Last Update Posted: January 18, 2012
Last Verified: January 2012
Keywords provided by Southwest Oncology Group:
Additional relevant MeSH terms:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue