S0344 Intralesional Resection in Treating Patients With Chondrosarcoma of the Bone
This study has been completed.
Sponsor:
Southwest Oncology Group
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
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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
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 May 19, 2013