S0344 Intralesional Resection in Treating Patients With Chondrosarcoma of the Bone

NCT00096213 | Completed Phase 2

• 4 other identifiers: CDR0000390349U10CA032102S0344ACOSOG-S0344
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 23

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.

Conditions

Sarcoma

Keywords

chondrosarcoma

Outcome Measures

Primary Outcomes (1)

• Probability of local complications

  two years

Secondary Outcomes (2)

• Probability of local recurrence and development of metastatic disease

  5 years

• Impact of musculoskeletal tumor reconstruction on functional status

  two years

Study Arms (1)

surgery

OTHER

intralesional resection

Procedure: conventional surgery

Interventions

conventional surgery PROCEDURE

surgery

surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator
• American College of Surgeons: collaborator

Study Sites (23)

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Aurora, Colorado, 80045, United States

Location

University of Florida Shands Cancer Center

Gainesville, Florida, 32610-0232, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

William Beaumont Hospital - Royal Oak Campus

Royal Oak, Michigan, 48073, United States

Location

University of New Mexico Cancer Research and Treatment Center

Albuquerque, New Mexico, 87131-5636, United States

Location

Akron City Hospital

Akron, Ohio, 44309-2090, United States

Location

Oregon Health & Science University Cancer Institute

Portland, Oregon, 97239-3098, United States

Location

Presbyterian Hospital of Dallas

Dallas, Texas, 75231, United States

Location

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112, United States

Location

St. Joseph Cancer Center

Bellingham, Washington, 98225, United States

Location

Olympic Hematology and Oncology

Bremerton, Washington, 98310, United States

Location

Skagit Valley Hospital Cancer Care Center

Mount Vernon, Washington, 98273, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98104, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Minor and James Medical, PLLC

Seattle, Washington, 98104, United States

Location

Group Health Central Hospital

Seattle, Washington, 98112, United States

Location

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, 98122-4307, United States

Location

Polyclinic First Hill

Seattle, Washington, 98122, United States

Location

University Cancer Center at University of Washington Medical Center

Seattle, Washington, 98195-6043, United States

Location

North Puget Oncology at United General Hospital

Sedro-Woolley, Washington, 98284, United States

Location

Cancer Care Northwest - Spokane South

Spokane, Washington, 99202, United States

Location

Wenatchee Valley Medical Center

Wenatchee, Washington, 98801-2028, United States

Location

MeSH Terms

Conditions

Sarcoma; Chondrosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Connective Tissue

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2004
• First Posted: November 9, 2004
• Study Start: December 1, 2004
• Primary Completion: April 1, 2006
• Study Completion: August 1, 2009
• Last Updated: January 18, 2012

Record last verified: 2012-01

Locations

US (23)