S0344 Intralesional Resection in Treating Patients With Chondrosarcoma of the Bone

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2009-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sarcoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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surgery

intralesional resection

Group Type OTHER

conventional surgery

Intervention Type PROCEDURE

surgery

Interventions

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conventional surgery

surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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R. Lor Randall, MD, FACS

Role: STUDY_CHAIR

University of Utah

Janet S. Biermann, MD

Role: STUDY_CHAIR

University of Michigan Rogel Cancer Center

Edward Cheng, MD

Role: STUDY_CHAIR

Masonic Cancer Center, University of Minnesota

Locations

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Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

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

Aurora, Colorado, United States

Site Status

University of Florida Shands Cancer Center

Gainesville, Florida, United States

Site Status

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status

William Beaumont Hospital - Royal Oak Campus

Royal Oak, Michigan, United States

Site Status

University of New Mexico Cancer Research and Treatment Center

Albuquerque, New Mexico, United States

Site Status

Akron City Hospital

Akron, Ohio, United States

Site Status

Oregon Health & Science University Cancer Institute

Portland, Oregon, United States

Site Status

Presbyterian Hospital of Dallas

Dallas, Texas, United States

Site Status

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, United States

Site Status

St. Joseph Cancer Center

Bellingham, Washington, United States

Site Status

Olympic Hematology and Oncology

Bremerton, Washington, United States

Site Status