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Functional Outcomes Following Limb Sparing Surgery for Sarcoma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00508339
Recruitment Status : Withdrawn
First Posted : July 27, 2007
Last Update Posted : August 1, 2012
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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).

Condition or disease Intervention/treatment
Sarcoma Behavioral: Questionnaire

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 : September 2006
Primary Completion Date : October 2007
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  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. [ Time Frame: 1 Year ]


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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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00508339     History of Changes
Other Study ID Numbers: 2005-0111
First Posted: July 27, 2007    Key Record Dates
Last Update Posted: August 1, 2012
Last Verified: July 2012

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