Functional Outcomes Following Limb Sparing Surgery for Sarcoma Patients

NCT00508339 | Withdrawn

• 1 other identifier: 2005-0111
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives:

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

Conditions

Sarcoma

Keywords

Soft Tissue Sarcoma; Limb Sparing Surgery; Toronto Extremity Salvage Score; Radiotherapy; Quality of Life; Questionnaire; Survey; TESS

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

1

Patients with a diagnosis of soft tissue sarcoma.

Behavioral: Questionnaire

Interventions

Questionnaire BEHAVIORAL

Toronto Extremity Salvage Score (TESS) questionnaire.

Also known as: Survey

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of soft tissue sarcoma.

You may qualify if:

• Diagnosis of soft tissue sarcoma with histopathologic confirmation.
• Treatment protocol that includes pre-operative radiation therapy.
• Treatment protocol that includes limb-sparing surgical resection.
• Patient has received MD Anderson Cancer Center multidisciplinary care.
• Patient must be at least three years post-operative.

You may not qualify if:

• Previous radiotherapy to the local site.
• Presence of regional or distant metastases.
• Major medical co-morbidities (eg. cerebrovascular accident, congestive heart failure, concurrent malignancy) or disabilities unrelated to treatment for soft tissue sarcoma.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Sarcoma

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Charles E. Butler, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2007
• First Posted: July 27, 2007
• Study Start: September 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: August 1, 2012

Record last verified: 2012-07

Locations

US (1)