Immediate Implant Breast Reconstruction (ISIS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Centre Val d'Aurelle - Paul Lamarque
Sponsor:
Information provided by (Responsible Party):
Centre Val d'Aurelle - Paul Lamarque
ClinicalTrials.gov Identifier:
NCT02055937
First received: October 9, 2013
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Breast Cancer
Procedure: immediate implant breast reconstruction
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Immediate Implant Breast Reconstruction for Patients With Mastectomy Ans Post opérative Chest Wall Radiotherapy

Resource links provided by NLM:


Further study details as provided by Centre Val d'Aurelle - Paul Lamarque:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

    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:
  • The rate of Baker [ Time Frame: up to 36 months after surgery ] [ Designated as safety issue: No ]
    The rate of Baker grades 3/4 capsular contracture


Other Outcome Measures:
  • Cosmetic results [ Time Frame: up to 36 months after surgery ] [ Designated as safety issue: No ]
    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.

  • Functional results [ Time Frame: up to 36 months after surgery ] [ Designated as safety issue: No ]
    Functional results: patient satisfaction will be evaluated using a self-questionnaire

  • The rate of patients requiring breast implant removal [ Time Frame: up to 36 months after surgery ] [ Designated as safety issue: No ]
    The rate of patients requiring breast implant removal

  • Study of tolerance [ Time Frame: up to 36 months after surgery ] [ Designated as safety issue: No ]
    Study of the indesirable effect of the radiotherapy on the implant


Estimated Enrollment: 53
Study Start Date: October 2013
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    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™
Detailed Description:

non applicable

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02055937

Contacts
Contact: jean pierre bleuse 0033467613102 jean-pierre.bleuse@icm.unicancer.fr

Locations
France
Institut régional du Cancer - Montpellier - Val d'Aurelle Recruiting
Montpellier, France, 34000
Contact: jean pierre bleuse    0033467613102    jean-pierre.bleuse@icm.unicancer.fr   
Principal Investigator: philippe rouanet         
Sponsors and Collaborators
Centre Val d'Aurelle - Paul Lamarque
  More Information

Publications:
Responsible Party: Centre Val d'Aurelle - Paul Lamarque
ClinicalTrials.gov Identifier: NCT02055937     History of Changes
Other Study ID Numbers: VA2012/37, 2012-A01369-34
Study First Received: October 9, 2013
Last Updated: February 4, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Centre Val d'Aurelle - Paul Lamarque:
mastectomy, reconstruction

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014