S0344 Intralesional Resection in Treating Patients With Chondrosarcoma of the Bone

SWOG Cancer Research Network

Status and phase: Completed; Phase 2

Conditions: Sarcoma

Treatments: Procedure: conventional surgery

Study type: Interventional

Funder types: Other; NETWORK; NIH

Identifiers

NCT00096213

S0344 (Other Identifier)

CDR0000390349

ACOSOG-S0344 (Other Identifier)

U10CA032102 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

surgery

Other group

Description:

intralesional resection

Treatment:

Procedure: conventional surgery