ISIS: Immediate Implant Breast Reconstruction

Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle (Other)
Overall Status
Terminated
CT.gov ID
NCT02055937
Collaborator
(none)
53
1
1
55.9
0.9

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: immediate implant breast reconstruction
N/A

Detailed Description

non applicable

Study Design

Study Type:
Interventional
Actual Enrollment :
53 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Immediate Implant Breast Reconstruction for Patients With Mastectomy Ans Post opérative Chest Wall Radiotherapy
Study Start Date :
Oct 1, 2013
Actual Primary Completion Date :
Oct 1, 2015
Actual Study Completion Date :
May 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: immediate implant breast reconstruction

immediate implant breast reconstruction

Procedure: immediate implant breast reconstruction
Eligible patients will undergo radical mastectomy with axillary lymph nodes sampling followed by immediate and single-stage breast reconstruction using the acellular dermal matrix Strattice™

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. The rate of Baker [up to 36 months after surgery]

    The rate of Baker grades 3/4 capsular contracture

Other Outcome Measures

  1. Cosmetic results [up to 36 months after surgery]

    Cosmetic results: assessed by both the surgeon and patient (patient satisfaction will be evaluated using a self-questionnaire). Photographs of the breast will be taken at different times (Pre / per / postoperative) and the picture analysis will be reviewed by an independent committee.

  2. Functional results [up to 36 months after surgery]

    Functional results: patient satisfaction will be evaluated using a self-questionnaire

  3. The rate of patients requiring breast implant removal [up to 36 months after surgery]

    The rate of patients requiring breast implant removal

  4. Study of tolerance [up to 36 months after surgery]

    Study of the indesirable effect of the radiotherapy on the implant

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

  • Inability to attend or comply with interventions or follow-up scheduling, disability or difficulty preventing a proper understanding of trial instructions

  • Legal inability or restricted legal ability

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut régional du Cancer - Montpellier - Val d'Aurelle Montpellier France 34000

Sponsors and Collaborators

  • Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Institut du Cancer de Montpellier - Val d'Aurelle
ClinicalTrials.gov Identifier:
NCT02055937
Other Study ID Numbers:
  • VA2012/37
  • 2012-A01369-34
First Posted:
Feb 5, 2014
Last Update Posted:
Aug 10, 2020
Last Verified:
Aug 1, 2020
Keywords provided by Institut du Cancer de Montpellier - Val d'Aurelle

Study Results

No Results Posted as of Aug 10, 2020