Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer

NCT ID: NCT00845078

Last Updated: 2017-04-27

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-12-31

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.

Conditions

Breast; Radiotherapy; Aesthetics; Treatment Outcome; Surgical Reconstruction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Immediate reconstruction followed by radiation therapy

No interventions assigned to this group

2

Radiation therapy followed by delayed reconstruction

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julio A Clavijo-Alvarez, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Michael L Gimbel, MD

Role: STUDY_DIRECTOR

University of Pittsburgh

References

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.

Reference Type: BACKGROUND

PMID: 11373553 (View on PubMed)

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.

Reference Type: RESULT

PMID: 11420508 (View on PubMed)

Tran NV, Evans GR, Kroll SS, Baldwin BJ, Miller MJ, Reece GP, Robb GL. Postoperative adjuvant irradiation: effects on tranverse rectus abdominis muscle flap breast reconstruction. Plast Reconstr Surg. 2000 Aug;106(2):313-7; discussion 318-20. doi: 10.1097/00006534-200008000-00011.

Reference Type: RESULT

PMID: 10946929 (View on PubMed)

Kroll SS, Robb GL, Reece GP, Miller MJ, Evans GR, Baldwin BJ, Wang B, Schusterman MA. Does prior irradiation increase the risk of total or partial free-flap loss? J Reconstr Microsurg. 1998 May;14(4):263-8. doi: 10.1055/s-2007-1000179.

Reference Type: RESULT

PMID: 9618094 (View on PubMed)

Kroll SS, Coffey JA Jr, Winn RJ, Schusterman MA. A comparison of factors affecting aesthetic outcomes of TRAM flap breast reconstructions. Plast Reconstr Surg. 1995 Sep;96(4):860-4. doi: 10.1097/00006534-199509001-00015.

Reference Type: RESULT

PMID: 7652060 (View on PubMed)

Other Identifiers

PRO07120002

Identifier Type: -

Identifier Source: org_study_id