Study Stopped
Slow recruitment rate
Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella
GRATSEC
1 other identifier
interventional
196
1 country
23
Brief Summary
This is a phase III randomized multi-center study of equivalence comparing the radiological follow-up for patients benefiting from the correction of the esthetical relapse of the preservative treatment by fatty transfer compared with a simple supervision. It is planned that 440 patients participate in this study which plans to compare 2 groups of patients: a group of patients which will benefit from the surgical treatment by transfer of fatty tissue and a group of patients under simple supervision. follow-up consultations are planned in 10 in 45 days post-surgery then at 3 months, 6 months, 12 months and 5 years to look for the expected unwanted effects in relation with the surgery but also to estimate the impact of the fatty transfer on the rate of local and\\or from a distance relapse. During these consultations, the surgeon and the patient will also estimate the cosmetic result of the surgery thanks to a questionnaire of cosmetic evaluation and to standardized photos.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 breast-cancer
Started Feb 2010
Typical duration for phase_3 breast-cancer
23 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
First Submitted
Initial submission to the registry
December 14, 2009
CompletedFirst Posted
Study publicly available on registry
December 18, 2009
CompletedStudy Start
First participant enrolled
February 8, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 21, 2017
CompletedAugust 22, 2018
August 1, 2018
5.6 years
December 14, 2009
August 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Verify that the disturbances of the radiological follow-up in 1 year will not be more frequent for the patient benefiting from fatty transfer with regard to a simple surveillance.
1 year
Secondary Outcomes (2)
Estimate the technique on the cosmetic plan : On the quality and on the stability of the result. On the satisfaction of the patient.
1 year
Estimate the technique on the carcinological plan : Estimate the rate of local relapse and\or in distance. Estimate the rate of survival of the patients.
1 year
Study Arms (2)
surgery by fatty tissue transfer
EXPERIMENTALsimple supervision
NO INTERVENTIONInterventions
It will be proceeded to aspiration of the fat at the level of the natural steatomeries (hip, stomach), then in a transfer of the fat prepared in the breast by following the standardized protocol.
Eligibility Criteria
You may qualify if:
- History of breast cancer treated by conservative surgery .
- Moderate Deformations (Type I and II of the classification of Clough).
- Delay with regard to the end of the radiotherapy superior or equal to one-year-old.
- Moderated radio-dystrophies (\< Grade 2 of the score LENT/SOMA).
- Signature of the informed consent
- Patient benefiting from social security
- Patient of more than 18 years old
You may not qualify if:
- Abnormal radiological assessment (ACR3, ACR4 or ACR5)
- Absence of fatty excess .
- radio surgical relapses with vast fibroses of the breast (\> Grade 2 of the score LENT/SOMA).
- Patient under 18 years old.
- administrative difficulties: impossibility to provide enlightened information to the patient, the refusal to sign the consent .
- pregnant women or breast feeding women
- patient under legal guardianship
- bilateral breast cancer regardless histologic type.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
CHU de Besançon
Besançon, 25030, France
Clinique Saint Antoine
Bois-Guillaume, 76230, France
CHU Pellegrin
Bordeaux, 33076, France
Institut Bergonie
Bordeaux, 33076, France
Pole de Sante de Leonard de Vinci
Chambray-lès-Tours, 37145, France
Hopital Henri Mondor
Créteil, 94010, France
Centre Hospitalier La Croix Rousse
Lyon, 69004, France
Hopital Edouard Herriot
Lyon, 69437, France
CHR Marseille Conception
Marseille, 13005, France
Institut Paoli Calmettes
Marseille, 13273, France
Centre Val d'Aurelle
Montpellier, 34298, France
Clinique Brétéché
Nantes, 44000, France
INSTITUT CURIE - Site Paris
Paris, 75005, France
Hopital Saint Louis
Paris, 75010, France
Centre Eugene Marquis
Rennes, 35042, France
Centre Henri Becquerel
Rouen, 76038, France
INSTITUT CURIE - René Huguenin
Saint-Cloud, 92210, France
INSTITUT DE CANCEROLOGIE DE L'OUEST - Centre René Gauducheau
Saint-Herblain, 44805, France
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091, France
CHU Rangueil
Toulouse, 31000, France
Institut Claudius Regaud
Toulouse, 31059, France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511, France
Institut Gustave Roussy
Villejuif, 94805, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ignacio GARRIDO, MD
Institut Claudius Regaud
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2009
First Posted
December 18, 2009
Study Start
February 8, 2010
Primary Completion
October 1, 2015
Study Completion
February 21, 2017
Last Updated
August 22, 2018
Record last verified: 2018-08