A Phase II Surgical Trial Of Intralesional Resection Of Low-Grade Intracompartmental Chondrosarcoma Of Bone
18 Years
N/A
Both
Sarcoma
Trial Information
A Phase II Surgical Trial Of Intralesional Resection Of Low-Grade Intracompartmental Chondrosarcoma Of Bone
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.
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Probability of local complications
Outcome Time Frame:
two years
Safety Issue:
No
Principal Investigator
R. Lor Randall, MD, FACS
Investigator Role:
Study Chair
Investigator Affiliation:
University of Utah
Authority:
United States: Federal Government
Study ID:
CDR0000390349
NCT ID:
NCT00096213
Start Date:
December 2004
Completion Date:
August 2009
Related Keywords:
- Sarcoma
- chondrosarcoma
- Chondrosarcoma
- Sarcoma
Name | Location |
|---|---|
| Akron City Hospital | Akron, Ohio 44304 |
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
| University of New Mexico Cancer Research and Treatment Center | Albuquerque, New Mexico 87131 |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
| University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
| William Beaumont Hospital - Royal Oak Campus | Royal Oak, Michigan 48073 |
| Olympic Hematology and Oncology | Bremerton, Washington 98310 |
| Skagit Valley Hospital Cancer Care Center | Mt. Vernon, Washington 98273 |
| University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
| Harborview Medical Center | Seattle, Washington 98104 |
| Group Health Central Hospital | Seattle, Washington 98104 |
| North Puget Oncology at United General Hospital | Sedro-Wooley, Washington 98284 |
| Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
| Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
| Minor and James Medical, PLLC | Seattle, Washington 98104 |
| Polyclinic First Hill | Seattle, Washington 98122 |
| St. Joseph Cancer Center | Bellingham, Washington 98225 |
| Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
| Oregon Health & Science University Cancer Institute | Portland, Oregon 97239-3098 |
| Presbyterian Hospital of Dallas | Dallas, Texas 75231 |
