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Immediate Implant Breast Reconstruction (ISIS)

This study has been terminated.
(autorities vorbidden this dispositif in other trial)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02055937
First Posted: February 5, 2014
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Institut du Cancer de Montpellier - Val d'Aurelle
  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: 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

Resource links provided by NLM:


Further study details as provided by Institut du Cancer de Montpellier - Val d'Aurelle:

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 ]

    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 ]
    The rate of Baker grades 3/4 capsular contracture


Other Outcome Measures:
  • Cosmetic results [ Time Frame: 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.

  • Functional results [ Time Frame: up to 36 months after surgery ]
    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 ]
    The rate of patients requiring breast implant removal

  • Study of tolerance [ Time Frame: up to 36 months after surgery ]
    Study of the indesirable effect of the radiotherapy on the implant


Enrollment: 53
Study Start Date: October 2013
Estimated Study Completion Date: October 2017
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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™

Detailed Description:
non applicable
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055937


Locations
France
Institut régional du Cancer - Montpellier - Val d'Aurelle
Montpellier, France, 34000
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
  More Information

Publications:
Responsible Party: Institut du Cancer de Montpellier - Val d'Aurelle
ClinicalTrials.gov Identifier: NCT02055937     History of Changes
Other Study ID Numbers: VA2012/37
2012-A01369-34 ( Registry Identifier: RCB )
First Submitted: October 9, 2013
First Posted: February 5, 2014
Last Update Posted: August 22, 2017
Last Verified: August 2017

Keywords provided by Institut du Cancer de Montpellier - Val d'Aurelle:
mastectomy, reconstruction