Immediate Implant Breast Reconstruction (ISIS)
August 7, 2020 updated by: Institut du Cancer de Montpellier - Val d'Aurelle
Immediate Implant Breast Reconstruction for Patients With Mastectomy Ans Post opérative Chest Wall Radiotherapy
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
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
non applicable
Study Type
Interventional
Enrollment (Actual)
53
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Montpellier, France, 34000
- Institut régional du Cancer - Montpellier - Val d'Aurelle
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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™
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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:
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confirm the feasibility of the therapeutic sequence at 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The rate of Baker
Time Frame: up to 36 months after surgery
|
The rate of Baker grades 3/4 capsular contracture
|
up to 36 months after surgery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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up to 36 months after surgery
|
|
Functional results
Time Frame: up to 36 months after surgery
|
Functional results: patient satisfaction will be evaluated using a self-questionnaire
|
up to 36 months after surgery
|
|
The rate of patients requiring breast implant removal
Time Frame: up to 36 months after surgery
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The rate of patients requiring breast implant removal
|
up to 36 months after surgery
|
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Study of tolerance
Time Frame: up to 36 months after surgery
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Study of the indesirable effect of the radiotherapy on the implant
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up to 36 months after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Christian CK, Niland J, Edge SB, Ottesen RA, Hughes ME, Theriault R, Wilson J, Hergrueter CA, Weeks JC. A multi-institutional analysis of the socioeconomic determinants of breast reconstruction: a study of the National Comprehensive Cancer Network. Ann Surg. 2006 Feb;243(2):241-9. doi: 10.1097/01.sla.0000197738.63512.23.
- Lambert K, Mokbel K. Does post-mastectomy radiotherapy represent a contraindication to skin-sparing mastectomy and immediate reconstruction: an update. Surg Oncol. 2012 Jun;21(2):e67-74. doi: 10.1016/j.suronc.2011.12.007. Epub 2012 Jan 30.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
May 30, 2018
Study Registration Dates
First Submitted
October 9, 2013
First Submitted That Met QC Criteria
February 4, 2014
First Posted (Estimate)
February 5, 2014
Study Record Updates
Last Update Posted (Actual)
August 10, 2020
Last Update Submitted That Met QC Criteria
August 7, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- VA2012/37
- 2012-A01369-34 (Registry Identifier: RCB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.