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S0344 Intralesional Resection in Treating Patients With Chondrosarcoma of the Bone

Primary Purpose

Sarcoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
conventional surgery
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring chondrosarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
  • University of Colorado Cancer Center at University of Colorado Health Sciences Center
  • University of Florida Shands Cancer Center
  • University of Michigan Comprehensive Cancer Center
  • William Beaumont Hospital - Royal Oak Campus
  • University of New Mexico Cancer Research and Treatment Center
  • Akron City Hospital
  • Oregon Health & Science University Cancer Institute
  • Presbyterian Hospital of Dallas
  • Huntsman Cancer Institute at University of Utah
  • St. Joseph Cancer Center
  • Olympic Hematology and Oncology
  • Skagit Valley Hospital Cancer Care Center
  • Fred Hutchinson Cancer Research Center
  • Harborview Medical Center
  • Minor and James Medical, PLLC
  • Group Health Central Hospital
  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
  • Polyclinic First Hill
  • University Cancer Center at University of Washington Medical Center
  • North Puget Oncology at United General Hospital
  • Cancer Care Northwest - Spokane South
  • Wenatchee Valley Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

surgery

Arm Description

intralesional resection

Outcomes

Primary Outcome Measures

Probability of local complications

Secondary Outcome Measures

Probability of local recurrence and development of metastatic disease
Impact of musculoskeletal tumor reconstruction on functional status

Full Information

First Posted
November 9, 2004
Last Updated
January 13, 2012
Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI), American College of Surgeons
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1. Study Identification

Unique Protocol Identification Number
NCT00096213
Brief Title
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

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI), American College of Surgeons

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
chondrosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
surgery
Arm Type
Other
Arm Description
intralesional resection
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Description
surgery
Primary Outcome Measure Information:
Title
Probability of local complications
Time Frame
two years
Secondary Outcome Measure Information:
Title
Probability of local recurrence and development of metastatic disease
Time Frame
5 years
Title
Impact of musculoskeletal tumor reconstruction on functional status
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R. Lor Randall, MD, FACS
Organizational Affiliation
University of Utah
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Janet S. Biermann, MD
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Edward Cheng, MD
Organizational Affiliation
Masonic Cancer Center, University of Minnesota
Official's Role
Study Chair
Facility Information:
Facility Name
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
University of Colorado Cancer Center at University of Colorado Health Sciences Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Florida Shands Cancer Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0232
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0942
Country
United States
Facility Name
William Beaumont Hospital - Royal Oak Campus
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
University of New Mexico Cancer Research and Treatment Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-5636
Country
United States
Facility Name
Akron City Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44309-2090
Country
United States
Facility Name
Oregon Health & Science University Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Presbyterian Hospital of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Huntsman Cancer Institute at University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
St. Joseph Cancer Center
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Olympic Hematology and Oncology
City
Bremerton
State/Province
Washington
ZIP/Postal Code
98310
Country
United States
Facility Name
Skagit Valley Hospital Cancer Care Center
City
Mt. Vernon
State/Province
Washington
ZIP/Postal Code
98273
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Minor and James Medical, PLLC
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Group Health Central Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98112
Country
United States
Facility Name
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122-4307
Country
United States
Facility Name
Polyclinic First Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
University Cancer Center at University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-6043
Country
United States
Facility Name
North Puget Oncology at United General Hospital
City
Sedro-Wooley
State/Province
Washington
ZIP/Postal Code
98284
Country
United States
Facility Name
Cancer Care Northwest - Spokane South
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Wenatchee Valley Medical Center
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801-2028
Country
United States

12. IPD Sharing Statement

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S0344 Intralesional Resection in Treating Patients With Chondrosarcoma of the Bone

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