ISIS: Immediate Implant Breast Reconstruction
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 |
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N/A |
Detailed Description
non applicable
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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™
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Outcome Measures
Primary Outcome Measures
- 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
- The rate of Baker [up to 36 months after surgery]
The rate of Baker grades 3/4 capsular contracture
Other Outcome Measures
- 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.
- Functional results [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 [up to 36 months after surgery]
The rate of patients requiring breast implant removal
- Study of tolerance [up to 36 months after surgery]
Study of the indesirable effect of the radiotherapy on the implant
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologically confirmed breast carcinoma
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Patients planned for mastectomy with immediate single stage breast reconstruction using an acellular dermal matrix (Strattice™, LifeCell Corporation)
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Patients planned to receive postoperative chest wall irradiation
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Age ≥ 18 years old
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WHO performance status 0-1
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Affiliation to a social security system
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Informed consent signed prior any study specific procedures
Exclusion Criteria:
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Inflammatory breast cancer
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Tumors with extensive involvement of the skin
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Use of tissue expander
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Indication of postoperative chemotherapy
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Patients planned for bilateral mastectomy
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History of previously treated ipsilateral breast carcinoma
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Usual contraindications for ADM
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Medical debility precluding surgical treatment
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Psychological, social, geographical disorders or any other condition that would preclude study compliance (treatment modalities and study follow-up).
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Pregnancy or breast feeding
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Inability to attend or comply with interventions or follow-up scheduling, disability or difficulty preventing a proper understanding of trial instructions
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Legal inability or restricted legal ability
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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
- 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.
- 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. Review.
- VA2012/37
- 2012-A01369-34