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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2011 by Clinique Clementville
Sponsor:
Information provided by:
Clinique Clementville
ClinicalTrials.gov Identifier:
NCT01199354
First received: September 8, 2010
Last updated: June 8, 2011
Last verified: June 2011
  Purpose

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Clinique Clementville:

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

Estimated Enrollment: 80
Study Start Date: July 2010
Estimated Study Completion Date: July 2017
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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders 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...
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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   
CRLCC Val d'Aurelle Not yet recruiting
Montpellier, France
Contact: Marian Gutowski       gutowski@valdorel.fnclcc.fr   
Clinique Clementville Recruiting
Montpellier, France
Contact: Pierre Berrand       pa.bertrand@wanadoo.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
  More Information

No publications provided

Responsible Party: Jean-Louis Bonneton, Clinique Clementville
ClinicalTrials.gov Identifier: NCT01199354     History of Changes
Other Study ID Numbers: CLEM-01
Study First Received: September 8, 2010
Last Updated: June 8, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Clinique Clementville:
Invasive breast carcinoma

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

ClinicalTrials.gov processed this record on August 18, 2014