Immediate Implant Breast Reconstruction for Patients With Mastectomy Ans Post opérative Chest Wall Radiotherapy

Institut du Cancer de Montpellier - Val d'Aurelle1 site in 1 country53 target enrollmentOctober 2013

ConditionsBreast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Enrollment: 53
Locations: 1
Primary Endpoint: Success is defined as a complete therapeutic sequence (surgery + RT) without any significant complication at 6 months.
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to study the impact of the immediate implant breast reconstruction for patients with mastectomy and postoperative chest wall radiotherapy

Detailed Description

non applicable

Registry

clinicaltrials.gov

Start Date

October 2013

End Date

May 30, 2018

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed breast carcinoma
•Patients planned for mastectomy with immediate single stage breast reconstruction using an acellular dermal matrix (Strattice™, LifeCell Corporation)
•Patients planned to receive postoperative chest wall irradiation
•Age ≥ 18 years old
•WHO performance status 0-1
•Affiliation to a social security system
•Informed consent signed prior any study specific procedures

Exclusion Criteria

•Inflammatory breast cancer
•Tumors with extensive involvement of the skin
•Use of tissue expander
•Indication of postoperative chemotherapy
•Patients planned for bilateral mastectomy
•History of previously treated ipsilateral breast carcinoma
•Usual contraindications for ADM
•Medical debility precluding surgical treatment
•Psychological, social, geographical disorders or any other condition that would preclude study compliance (treatment modalities and study follow-up).
•Pregnancy or breast feeding

Outcomes

Primary Outcomes

Success is defined as a complete therapeutic sequence (surgery + RT) without any significant complication at 6 months.

Time Frame: confirm the feasibility of the therapeutic sequence at 6 months

Success is defined as a complete therapeutic sequence (surgery + RT) without any significant complication at 6 months. Significant complication is defined as: * Any event delaying RT (delay surgery/RT \> 3 months) * Any event preventing patients from receiving radiotherapy within 6 months after surgery