Clinical trial NCT00096213: S0344 Intralesional Resection in Treating Patients With Chondrosarcoma of the Bone
Official title: A Phase II Surgical Trial Of Intralesional Resection Of Low-Grade Intracompartmental Chondrosarcoma Of Bone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sarcoma
Keywords: chondrosarcoma
Lead sponsor: SWOG Cancer Research Network
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: American College of Surgeons
First posted: 2004-11-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Probability of local complications
timeFrame: two years
Secondary outcomes:
measure: Probability of local recurrence and development of metastatic disease
timeFrame: 5 years
measure: Impact of musculoskeletal tumor reconstruction on functional status
timeFrame: two years
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
state: Arkansas
city: Aurora
country: United States
facility: University of Colorado Cancer Center at University of Colorado Health Sciences Center
state: Colorado
city: Gainesville
country: United States
facility: University of Florida Shands Cancer Center
state: Florida
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital - Royal Oak Campus
state: Michigan
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Research and Treatment Center
state: New Mexico
city: Akron
country: United States
facility: Akron City Hospital
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University Cancer Institute
state: Oregon
city: Dallas
country: United States
facility: Presbyterian Hospital of Dallas
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute at University of Utah
state: Utah
city: Bellingham
country: United States
facility: St. Joseph Cancer Center
state: Washington
city: Bremerton
country: United States
facility: Olympic Hematology and Oncology
state: Washington
city: Mt. Vernon
country: United States
facility: Skagit Valley Hospital Cancer Care Center
state: Washington
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Seattle
country: United States
facility: Minor and James Medical, PLLC
state: Washington
city: Seattle
country: United States
facility: Group Health Central Hospital
state: Washington
city: Seattle
country: United States
facility: Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
state: Washington
city: Seattle
country: United States
facility: Polyclinic First Hill
state: Washington
city: Seattle
country: United States
facility: University Cancer Center at University of Washington Medical Center
state: Washington
city: Sedro-Wooley
country: United States
facility: North Puget Oncology at United General Hospital
state: Washington
city: Spokane
country: United States
facility: Cancer Care Northwest - Spokane South
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Medical Center
state: Washington
Study officials:
affiliation: University of Utah
name: R. Lor Randall, MD, FACS
role: STUDY_CHAIR
affiliation: University of Michigan Rogel Cancer Center
name: Janet S. Biermann, MD
role: STUDY_CHAIR
affiliation: Masonic Cancer Center, University of Minnesota
name: Edward Cheng, MD
role: STUDY_CHAIR
References: