S0344 Intralesional Resection in Treating Patients With Chondrosarcoma of the Bone

January 13, 2012 updated by: Southwest Oncology Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: surgery
intralesional resection
Procedure: conventional surgery
surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Probability of local complications
Time Frame: two years
two years

Secondary Outcome Measures

Outcome Measure
Time Frame
Probability of local recurrence and development of metastatic disease
Time Frame: 5 years
5 years
Impact of musculoskeletal tumor reconstruction on functional status
Time Frame: two years
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)
American College of Surgeons

Investigators

  • Study Chair: Janet S. Biermann, MD, University of Michigan Rogel Cancer Center
  • Study Chair: Edward Cheng, MD, Masonic Cancer Center, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (ACTUAL)

April 1, 2006

Study Completion (ACTUAL)

August 1, 2009

Study Registration Dates

First Submitted

November 9, 2004

First Submitted That Met QC Criteria

November 8, 2004

First Posted (ESTIMATE)

November 9, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

January 18, 2012

Last Update Submitted That Met QC Criteria

January 13, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000390349
  • U10CA032102 (U.S. NIH Grant/Contract)
  • S0344 (OTHER: SWOG)
  • ACOSOG-S0344 (OTHER: ACOSOG)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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