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Functional Outcomes Following Limb Sparing Surgery for Sarcoma Patients

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00508339
First received: July 26, 2007
Last updated: July 31, 2012
Last verified: July 2012
History of Changes
  Purpose

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
Sarcoma
 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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
1
Patients with a diagnosis of soft tissue sarcoma.
 Behavioral: Questionnaire
Toronto Extremity Salvage Score (TESS) questionnaire.
Other Name: Survey

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with a diagnosis of soft tissue sarcoma.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00508339

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

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00508339     History of Changes
Other Study ID Numbers: 2005-0111
Study First Received: July 26, 2007
Last Updated: July 31, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 21, 2013