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Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella (GRATSEC)

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
fatty tissue transfer
Sponsored by
Institut Claudius Regaud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer treated by conservative surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • History of breast cancer treated by conservative surgery .
  • Normal inclusion radiological assessment normal (ACR1 or ACR2)
  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • CHU de Besançon
  • Clinique Saint Antoine
  • CHU Pellegrin
  • Institut Bergonie
  • Pole de Sante de Leonard de Vinci
  • Hopital Henri Mondor
  • Centre Hospitalier La Croix Rousse
  • Hopital Edouard Herriot
  • CHR Marseille Conception
  • Institut Paoli Calmettes
  • Centre Val d'Aurelle
  • Clinique Brétéché
  • INSTITUT CURIE - Site Paris
  • Hopital Saint Louis
  • Centre Eugene Marquis
  • Centre Henri Becquerel
  • INSTITUT CURIE - René Huguenin
  • INSTITUT DE CANCEROLOGIE DE L'OUEST - Centre René Gauducheau
  • Hôpitaux Universitaires de Strasbourg
  • CHU Rangueil
  • Institut Claudius Regaud
  • Centre Alexis Vautrin
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

surgery by fatty tissue transfer

simple supervision

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Estimate the technique on the cosmetic plan : On the quality and on the stability of the result. On the satisfaction of the patient.
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.

Full Information

First Posted
December 14, 2009
Last Updated
August 21, 2018
Sponsor
Institut Claudius Regaud
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1. Study Identification

Unique Protocol Identification Number
NCT01035268
Brief Title
Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella
Acronym
GRATSEC
Official Title
Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella. Adipocyte Transplant for Esthetical Relapse Treatment of Breast Conservative Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment rate
Study Start Date
February 8, 2010 (Actual)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
February 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Claudius Regaud

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer treated by conservative surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
196 (Actual)

8. Arms, Groups, and Interventions

Arm Title
surgery by fatty tissue transfer
Arm Type
Experimental
Arm Title
simple supervision
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
fatty tissue transfer
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Estimate the technique on the cosmetic plan : On the quality and on the stability of the result. On the satisfaction of the patient.
Time Frame
1 year
Title
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.
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of breast cancer treated by conservative surgery . Normal inclusion radiological assessment normal (ACR1 or ACR2) 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ignacio GARRIDO, MD
Organizational Affiliation
Institut Claudius Regaud
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Besançon
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
Clinique Saint Antoine
City
Bois-Guillaume
ZIP/Postal Code
76230
Country
France
Facility Name
CHU Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Pole de Sante de Leonard de Vinci
City
Chambray-Les-Tours
ZIP/Postal Code
37145
Country
France
Facility Name
Hopital Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Centre Hospitalier La Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
Hopital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
CHR Marseille Conception
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Clinique Brétéché
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
INSTITUT CURIE - Site Paris
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Hopital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
INSTITUT CURIE - René Huguenin
City
Saint-Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
INSTITUT DE CANCEROLOGIE DE L'OUEST - Centre René Gauducheau
City
Saint-Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
CHU Rangueil
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Centre Alexis Vautrin
City
Vandoeuvre-lès-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

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Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella

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