Functional Outcomes Following Limb Sparing Surgery for Sa... | NCT00508339

Studies
Functional Outcomes Following Limb Sparing Surgery for Sarcoma Patients

NCT00508339

Sponsor

M.D. Anderson Cancer Center

Status

Withdrawn

Last Update Posted

Aug 1, 2012Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Sarcoma

Interventions

Questionnaire

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Oct 2007Actual

Completion Date

Oct 2007Actual

First Submitted Date

Jul 26, 2007

First Submission Date that Met QC Criteria

Jul 26, 2007

First Posted Date

Jul 27, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2012

Last Update Posted Date

Aug 1, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Primary Objectives:

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.
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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Patients with a diagnosis of soft tissue sarcoma.	Behavioral: Questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Behavioral	Toronto Extremity Salvage Score (TESS) questionnaire.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.		1 Year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of soft tissue sarcoma with histopathologic confirmation.
Treatment protocol that includes pre-operative radiation therapy.
Treatment protocol that includes limb-sparing surgical resection.
Patient has received MD Anderson Cancer Center multidisciplinary care.
Patient must be at least three years post-operative.

Exclusion Criteria:

Previous radiotherapy to the local site.
Presence of regional or distant metastases.
Major medical co-morbidities (eg. cerebrovascular accident, congestive heart failure, concurrent malignancy) or disabilities unrelated to treatment for soft tissue sarcoma.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with a diagnosis of soft tissue sarcoma.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charles E. Butler, MD	M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
U.T.M.D. Anderson Cancer Center		Houston	Texas	77030	United States

Condition Browse Module

MeSH Terms

ID	Term
D012509	Sarcoma

Ancestor Terms

ID	Term
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided