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

Phase 2
18 Years
Not Enrolling

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Trial Information

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


- 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

Inclusion Criteria


- Suspected low-grade intracompartmental chondrosarcoma, as defined by the following

- 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



- 18 and over

Performance status

- Not specified

Life expectancy

- Not specified


- Not specified


- Not specified


- Not specified


- 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


Biologic therapy

- No prior biologic therapy for this tumor


- No prior chemotherapy for this tumor

Endocrine therapy

- Not specified


- No prior radiotherapy for this tumor


- No prior surgery for this tumor except biopsy*

- No concurrent intramedullary fixation NOTE: *Biopsy is not required


- No prior investigational anticancer agents for this tumor

Type of Study:


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:


Principal Investigator

R. Lor Randall, MD, FACS

Investigator Role:

Study Chair

Investigator Affiliation:

University of Utah


United States: Federal Government

Study ID:




Start Date:

December 2004

Completion Date:

August 2009

Related Keywords:

  • Sarcoma
  • chondrosarcoma
  • Chondrosarcoma
  • Sarcoma



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