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SarcomaPhase 2NCT00096213

S0344 Intralesional Resection in Treating Patients With Chondrosarcoma of the Bone

A Phase 2 study testing conventional surgery in people with Sarcoma, run by SWOG Cancer Research Network at 23 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcoma
What is being tested?
conventional surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
23 sitesUnited States
Study dates
Dec 2004to Aug 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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 locations and contacts

23 sites in 1 country.

23 sites in 1 country

United States23 sites

  • Akron City Hospital

    Akron, Ohio, 44309-2090

  • University of New Mexico Cancer Research and Treatment Center

    Albuquerque, New Mexico, 87131-5636

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0942

  • University of Colorado Cancer Center at University of Colorado Health Sciences Center

    Aurora, Colorado, 80045

  • St. Joseph Cancer Center

    Bellingham, Washington, 98225

  • Olympic Hematology and Oncology

    Bremerton, Washington, 98310

  • Presbyterian Hospital of Dallas

    Dallas, Texas, 75231

  • University of Florida Shands Cancer Center

    Gainesville, Florida, 32610-0232

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Skagit Valley Hospital Cancer Care Center

    Mount Vernon, Washington, 98273

  • Oregon Health & Science University Cancer Institute

    Portland, Oregon, 97239-3098

  • William Beaumont Hospital - Royal Oak Campus

    Royal Oak, Michigan, 48073

  • Huntsman Cancer Institute at University of Utah

    Salt Lake City, Utah, 84112

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98104

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Minor and James Medical, PLLC

    Seattle, Washington, 98104

  • Group Health Central Hospital

    Seattle, Washington, 98112

  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98122-4307

  • Polyclinic First Hill

    Seattle, Washington, 98122

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195-6043

  • North Puget Oncology at United General Hospital

    Sedro-Woolley, Washington, 98284

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801-2028

Other trials in United States

About this study

Official title: A Phase II Surgical Trial Of Intralesional Resection Of Low-Grade Intracompartmental Chondrosarcoma Of 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.

Read the 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.

Conditions
Sarcoma
Keywords
chondrosarcoma
Medical subject headings
Sarcoma, Chondrosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00096213
Study groupRoleWhat they receive
surgeryOtherintralesional resection
Receives: Procedure: conventional surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Probability of local complications

    Measured: two years

Secondary outcomes (2)

  1. Probability of local recurrence and development of metastatic disease

    Measured: 5 years

  2. Impact of musculoskeletal tumor reconstruction on functional status

    Measured: two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2004 (estimated)
  2. Study startDec 2004
  3. Primary completionApr 2006
  4. Study completionAug 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00096213
Sponsor's protocol ID
CDR0000390349
Other IDs
U10CA032102, S0344, ACOSOG-S0344
Status last verified
Jan 2012
First submitted
9 Nov 2004
Last updated
18 Jan 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing conventional surgery in people with Sarcoma, run by SWOG Cancer Research Network at 23 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Probability of local complications (time frame: two years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00096213.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2012.

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