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Functional Outcomes Following Limb Sparing Surgery for Sarcoma Patients

This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: July 26, 2007
Last updated: July 31, 2012
Last verified: July 2012

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).

Condition Intervention
Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Functional Outcomes Following Limb Sparing Surgery for Soft Tissue Sarcoma and Pre-Operative Radiotherapy

Resource links provided by NLM:

Further study details as provided by M.D. Anderson Cancer Center:

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. [ Time Frame: 1 Year ]

Enrollment: 0
Study Start Date: September 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with a diagnosis of soft tissue sarcoma.
Behavioral: Questionnaire
Toronto Extremity Salvage Score (TESS) questionnaire.
Other Name: Survey


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a diagnosis of soft tissue sarcoma.

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00508339

United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Charles E. Butler, MD M.D. Anderson Cancer Center
  More Information

Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00508339     History of Changes
Other Study ID Numbers: 2005-0111
Study First Received: July 26, 2007
Last Updated: July 31, 2012

Keywords provided by M.D. Anderson Cancer Center:
Soft Tissue Sarcoma
Limb Sparing Surgery
Toronto Extremity Salvage Score
Quality of Life

Additional relevant MeSH terms:
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms processed this record on May 25, 2017