Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
53 participants
INTERVENTIONAL
2013-10-31
2018-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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immediate implant breast reconstruction
immediate implant breast reconstruction
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™
Interventions
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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™
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Institut du Cancer de Montpellier - Val d'Aurelle
OTHER
Responsible Party
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Locations
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Institut régional du Cancer - Montpellier - Val d'Aurelle
Montpellier, , France
Countries
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References
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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.
Other Identifiers
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2012-A01369-34
Identifier Type: REGISTRY
Identifier Source: secondary_id
VA2012/37
Identifier Type: -
Identifier Source: org_study_id
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