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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Recruitment Status : Withdrawn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

Tracking Information
First Submitted Date July 26, 2007
First Posted Date July 27, 2007
Last Update Posted Date August 1, 2012
Study Start Date September 2006
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 6, 2008)
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 ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00508339 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Functional Outcomes Following Limb Sparing Surgery for Sarcoma Patients
Official Title Functional Outcomes Following Limb Sparing Surgery for Soft Tissue Sarcoma and Pre-Operative Radiotherapy
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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with a diagnosis of soft tissue sarcoma.
Condition Sarcoma
Intervention Behavioral: Questionnaire
Toronto Extremity Salvage Score (TESS) questionnaire.
Other Name: Survey
Study Groups/Cohorts 1
Patients with a diagnosis of soft tissue sarcoma.
Intervention: Behavioral: Questionnaire
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: February 6, 2008)
0
Original Estimated Enrollment
 (submitted: July 26, 2007)
175
Actual Study Completion Date October 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00508339
Other Study ID Numbers 2005-0111
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor M.D. Anderson Cancer Center
Collaborators Not Provided
Investigators
Principal Investigator: Charles E. Butler, MD M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date July 2012