Functional Outcomes Following Limb Sparing Surgery for Sarcoma Patients

Sarcoma Clinical Trial

Official title:

Functional Outcomes Following Limb Sparing Surgery for Soft Tissue Sarcoma and Pre-Operative Radiotherapy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00508339
• Other study ID #: 2005-0111
• Status: Withdrawn
• Phase: N/A
• First received: July 26, 2007
• Last updated: July 31, 2012
• Start date: September 2006
• Est. completion date: October 2007

Study information

• Verified date: July 2012
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Primary Objectives:

1. To classify the types of wound healing complications that occur after pre-operative radiation therapy and limb sparing resection for the treatment of soft tissue sarcomas of the extremity.

2. To evaluate the impact of each complication type on patient function and quality of life using the Toronto Extremity Salvage Score (TESS).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosis of soft tissue sarcoma with histopathologic confirmation.

2. Treatment protocol that includes pre-operative radiation therapy.

3. Treatment protocol that includes limb-sparing surgical resection.

4. Patient has received MD Anderson Cancer Center multidisciplinary care.

5. Patient must be at least three years post-operative.

Exclusion Criteria:

1. Previous radiotherapy to the local site.

2. Presence of regional or distant metastases.

3. Major medical co-morbidities (eg. cerebrovascular accident, congestive heart failure, concurrent malignancy) or disabilities unrelated to treatment for soft tissue sarcoma.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sarcoma

Intervention

Behavioral:
• Questionnaire
Toronto Extremity Salvage Score (TESS) questionnaire.

Locations

Country	Name	City	State
United States	U.T.M.D. Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endpoints for this study will be anatomic site, histological subtype, primary wound closure, wound complication type, need for secondary operation and type of secondary operation.		1 Year	No