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Skin Sparing Mastectomy and Immediate Breast Reconstruction With Latissimus Dorsi Flap After Neoadjuvant Chemotherapy and Radiotherapy (M-RIC) (M-RIC)

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ClinicalTrials.gov Identifier: NCT01199354
Recruitment Status : Unknown
Verified June 2011 by Clinique Clementville.
Recruitment status was:  Recruiting
First Posted : September 10, 2010
Last Update Posted : June 9, 2011
Sponsor:
Information provided by:
Clinique Clementville

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.

Condition or disease Intervention/treatment Phase
Breast Carcinoma Procedure: Mastectomy, preservation of the skin envelope,followed by immediate reconstruction with autologous latissimus dorsi flap. Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: 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.
Study Start Date : July 2010
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Mastectomy, preservation of the skin envelope,followed by immediate reconstruction with autologous latissimus dorsi flap.
    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.


Primary Outcome Measures :
  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 Outcome Measures :
  1. Rate of histological remission of the surgical specimen based on the anatomopathological examination


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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...

Exclusion Criteria:

  • 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...

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): NCT01199354


Contacts
Contact: Magali Lacroix m.lacroix@millenaire.fr

Locations
France
Polyclinique Urbain V Not yet recruiting
Avignon, France
Contact: Bernard Miramand       miramand@wanadoo.fr   
Polyclinique Urbain V Not yet recruiting
Avignon, France
Contact: Nicolas Sterkers       nica_sterckers@yahoo.fr   
Centre Jean Perrin Not yet recruiting
Clermont-Ferrand, France
Contact: Jacques Dauplat         
Groupe Hospitalier Mutualiste Clinique les Eaux Claires Not yet recruiting
Grenoble, France
Contact: Philippe Gabelle         
Centre Léon Bérard Not yet recruiting
Lyon, France
Contact: Catherine Bouteille       bouteill@lyon.fnclcc.fr   
Institut Paoli Calmettes Not yet recruiting
Marseille, France
Contact: Gilles Houvenaeghel       houvenag@marseille.free.fr   
Institut Paoli Calmettes Not yet recruiting
Marseille, France
Contact: Monique Cohen       chirurgie2@marseille.free.fr   
Clinique Clementville Recruiting
Montpellier, France
Contact: Pierre Berrand       pa.bertrand@wanadoo.fr   
CRLCC Val d'Aurelle Not yet recruiting
Montpellier, France
Contact: Marian Gutowski       gutowski@valdorel.fnclcc.fr   
Clinique Belledonne Not yet recruiting
Saint Martin d'Hères, France
Contact: Raoul Payan       desm.paya@wanadoo.fr   
Institut Claudius Regaud Not yet recruiting
Toulouse, France
Contact: Hélène Charitansky       helene.charitansky@orange.fr   
Sponsors and Collaborators
Clinique Clementville
Investigators
Principal Investigator: Cécile Zinzindhoue Clinique Clementville

Responsible Party: Jean-Louis Bonneton, Clinique Clementville
ClinicalTrials.gov Identifier: NCT01199354     History of Changes
Other Study ID Numbers: CLEM-01
First Posted: September 10, 2010    Key Record Dates
Last Update Posted: June 9, 2011
Last Verified: June 2011

Keywords provided by Clinique Clementville:
Invasive breast carcinoma

Additional relevant MeSH terms:
Carcinoma
Breast Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases