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Completed

NCT Number: NCT00096213

S0344 Intralesional Resection in Treating Patients With Chondrosarcoma of the Bone

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

conventional surgery

Procedure

surgery

Primary outcomes

  1. Probability of local complications

    Time frame: two years

Secondary outcomes

  1. Probability of local recurrence and development of metastatic disease

    Time frame: 5 years

  2. Impact of musculoskeletal tumor reconstruction on functional status

    Time frame: two years

Sponsors and collaborators

Lead sponsor

SWOG Cancer Research Network

Network

Collaborators

  • American College of Surgeons
  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2009
First posted
Nov 9, 2004
Registry last updated
Jan 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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