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


Phase 2
18 Years
N/A
Not Enrolling
Both
Sarcoma

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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 HospitalAkron, Ohio  44304
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
University of New Mexico Cancer Research and Treatment CenterAlbuquerque, New Mexico  87131
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
Olympic Hematology and OncologyBremerton, Washington  98310
Skagit Valley Hospital Cancer Care CenterMt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
North Puget Oncology at United General HospitalSedro-Wooley, Washington  98284
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
Minor and James Medical, PLLCSeattle, Washington  98104
Polyclinic First HillSeattle, Washington  98122
St. Joseph Cancer CenterBellingham, Washington  98225
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Oregon Health & Science University Cancer InstitutePortland, Oregon  97239-3098
Presbyterian Hospital of DallasDallas, Texas  75231