Functional Outcomes Following Limb Sparing Surgery for Sarcoma Patients

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00508339

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Primary Objectives:

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

Condition or Disease	Intervention/Treatment	Phase
Sarcoma	Behavioral: Questionnaire

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Sep 1, 2006

Actual Primary Completion Date :

Oct 1, 2007

Actual Study Completion Date :

Oct 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
1 Patients with a diagnosis of soft tissue sarcoma.	Behavioral: Questionnaire Toronto Extremity Salvage Score (TESS) questionnaire. Other Names: Survey

Arm

Intervention/Treatment

Patients with a diagnosis of soft tissue sarcoma.

Behavioral: Questionnaire

Toronto Extremity Salvage Score (TESS) questionnaire.

Other Names:

Survey

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.