Prospective Outcomes After Reconstruction and Radiotherap... | NCT00845078

Studies
Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer

NCT00845078

Sponsor

University of Pittsburgh

Status

Withdrawn

Last Update Posted

Apr 27, 2017Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Breast
Radiotherapy
Aesthetics
Treatment Outcome
Surgical Reconstruction

Interventions

Not provided

Countries

Not provided

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

Feb 2009

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Withdrawn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

Dec 2008

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Feb 13, 2009

First Submission Date that Met QC Criteria

Feb 13, 2009

First Posted Date

Feb 16, 2009Estimated

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

Apr 25, 2017

Last Update Posted Date

Apr 27, 2017Actual

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

This study examines the aesthetic outcomes of breast reconstruction after mastectomy for breast cancer in patients who require post-mastectomy radiation treatment. Patients will undergo autologous tissue breast reconstruction either in immediate fashion, prior to radiation treatment, or in delayed fashion, after radiation treatment. Both approaches are acceptable and are practiced clinically. this will be an observational prospective cohort study.

The investigators hypothesize that immediate autologous reconstruction patients who undergo subsequent radiation therapy have equivalent aesthetic outcome when compared to those in whom reconstruction is delayed until after radiation, with the additional benefit of avoiding the psychological side effects of breast amputation.

Detailed Description

Neo-adjuvant or adjuvant chemo-radiation remains one of the pillars for breast cancer treatment. (1, 2) Administration of radiation before or after autologous soft tissue reconstruction has being shown to alter the aesthetics of the new breast. (3-7) Currently, the optimal timing for autologous breast reconstruction in patients who need postmastectomy radiotherapy remains in debate between surgeons. (8) Various studies have tried to address this problem. However, most of them have been retrospective studies (3, 7, 9) and the prospective ones have not have enough patients, have mixed population of patients or the radiation protocols have not been normalized. (5, 6, 10)

We hypothesize that immediate autologous reconstruction patients who undergo subsequent radiation therapy have equivalent aesthetic outcome when compared to those in whom reconstruction is delayed until after radiation, with the additional benefit of avoiding the psychological side effects of breast amputation.

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		Immediate reconstruction followed by radiation therapy
2		Radiation therapy followed by delayed reconstruction

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Aesthetic breast scores		preoperative, 1 month, 6 months, 12 months, 24 months

Secondary Outcomes

Measure	Description	Time Frame
Quality of life (SF36)		preoperative, 1 month, 6 months, 12 months, 24 months
Patient Breast aesthetic perception (BR23)		preoperative, 1 month, 6 months, 12 months, 24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Breast cancer requiring mastectomy and post-mastectomy radiation
Desire for breast reconstruction after mastectomy

Exclusion Criteria:

Inflammatory breast cancer
Age < 18 years old
No desire for breast reconstruction
Women without need for postmastectomy radiation

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing mastectomy and radiation for breast cancer, who desire breast reconstruction after mastectomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Julio A Clavijo-Alvarez, MD	University of Pittsburgh	Principal Investigator
Michael L Gimbel, MD	University of Pittsburgh	Study Director

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11373553	Background	Edsander-Nord A, Brandberg Y, Wickman M. Quality of life, patients' satisfaction, and aesthetic outcome after pedicled or free TRAM flap breast surgery. Plast Reconstr Surg. 2001 Apr 15;107(5):1142-53; discussion 1154-5. doi: 10.1097/00006534-200104150-00007.
11420508	Result	Tran NV, Chang DW, Gupta A, Kroll SS, Robb GL. Comparison of immediate and delayed free TRAM flap breast reconstruction in patients receiving postmastectomy radiation therapy. Plast Reconstr Surg. 2001 Jul;108(1):78-82. doi: 10.1097/00006534-200107000-00013.