Skin Sparing Mastectomy and Immediate Breast Reconstruction With Latissimus Dorsi Flap After Neoadjuvant Chemotherapy and Radiotherapy (M-RIC)
M-RIC
Phase II Study: Assessing the Feasibility and Morbidity of Skin Sparing Mastectomy and Immediate Breast Reconstruction With Latissimus Dorsi Flap After Neoadjuvant Chemotherapy and Radiotherapy in Invasive Breast Carcinoma.
1 other identifier
interventional
80
1 country
11
Brief Summary
The aim of the study is to evaluate the feasibility and morbidity of skin sparing mastectomy and immediate breast reconstruction with latissimus dorsi flap after neoadjuvant chemotherapy and radiotherapy in invasive breast carcinoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2010
Longer than P75 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 8, 2010
CompletedFirst Posted
Study publicly available on registry
September 10, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedJune 9, 2011
June 1, 2011
September 8, 2010
June 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of skin necrosis
To evaluate the incidence of skin necrosis in case of treatment with skin sparing mastectomy and immediate breas reconstruction with latissimus dorsi myocutaneous flap after neoadjuvant chemotherapy and radiotherapy.
Secondary Outcomes (1)
Rate of histological remission of the surgical specimen based on the anatomopathological examination
Interventions
Mastectomy, preservation of the skin envelope, removal of the nipple-areolar complex and dissection of the axillary lymph nodes followed by immediate reconstruction with autologous latissimus dorsi flap with or without prosthesis.
Eligibility Criteria
You may qualify if:
- Women \< 75 year old
- Invasive breast carcinoma, indication for mastectomy
- Women Health Organization (WHO) score of 0 and 1, primary chemotherapy, external radiotherapy performed less than 8 week earlier...
You may not qualify if:
- Women older than 75
- Metastatic breast carcinoma
- Antecedents of previously treated homolateral breast carcinoma
- Documented cancer progression
- Smoker at the moment of the indication surgery
- Known diabetes, neoadjuvant hormonal treatment...
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Polyclinique Urbain V
Avignon, France
Polyclinique Urbain V
Avignon, France
Centre Jean Perrin
Clermont-Ferrand, France
Groupe Hospitalier Mutualiste Clinique les Eaux Claires
Grenoble, France
Centre Léon Bérard
Lyon, France
Institut Paoli Calmettes
Marseille, France
Institut Paoli Calmettes
Marseille, France
Clinique Clementville
Montpellier, France
CRLCC Val d'Aurelle
Montpellier, France
Clinique Belledonne
Saint-Martin-d'Hères, France
Institut Claudius Regaud
Toulouse, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cécile Zinzindhoue
Clinique Clementville
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 8, 2010
First Posted
September 10, 2010
Study Start
July 1, 2010
Study Completion
July 1, 2017
Last Updated
June 9, 2011
Record last verified: 2011-06