Functional Outcomes Following Limb Sparing Surgery for Sarcoma Patients

NCT ID: NCT00508339

Last Updated: 2012-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sarcoma

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Soft Tissue Sarcoma Limb Sparing Surgery Toronto Extremity Salvage Score Radiotherapy Quality of Life Questionnaire Survey TESS

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Patients with a diagnosis of soft tissue sarcoma.

Questionnaire

Intervention Type BEHAVIORAL

Toronto Extremity Salvage Score (TESS) questionnaire.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Questionnaire

Toronto Extremity Salvage Score (TESS) questionnaire.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Survey

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Charles E. Butler, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

U.T.M.D. Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2005-0111

Identifier Type: -

Identifier Source: org_study_id