S0344 Intralesional Resection in Treating Patients With Chondrosarcoma of the Bone
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|ClinicalTrials.gov Identifier: NCT00096213|
Recruitment Status : Completed
First Posted : November 9, 2004
Last Update Posted : January 18, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Procedure: conventional surgery||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Surgical Trial Of Intralesional Resection Of Low-Grade Intracompartmental Chondrosarcoma Of Bone|
|Study Start Date :||December 2004|
|Actual Primary Completion Date :||April 2006|
|Actual Study Completion Date :||August 2009|
Procedure: conventional surgery
- Probability of local complications [ Time Frame: two years ]
- Probability of local recurrence and development of metastatic disease [ Time Frame: 5 years ]
- Impact of musculoskeletal tumor reconstruction on functional status [ Time Frame: two years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00096213
|Study Chair:||R. Lor Randall, MD, FACS||University of Utah|
|Study Chair:||Janet S. Biermann, MD||University of Michigan Rogel Cancer Center|
|Study Chair:||Edward Cheng, MD||Masonic Cancer Center, University of Minnesota|