Clincosm LogoSign in Get a demo

GRATSEC: Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella

Sponsor
Institut Claudius Regaud (Other)
Overall Status
Terminated
CT.gov ID
NCT01035268
Collaborator
(none)
196
Enrollment
23
Locations
2
Arms
84.4
Actual Duration (Months)
8.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: fatty tissue transfer
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
196 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella. Adipocyte Transplant for Esthetical Relapse Treatment of Breast Conservative Treatment
Actual Study Start Date :
Feb 8, 2010
Actual Primary Completion Date :
Oct 1, 2015
Actual Study Completion Date :
Feb 21, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: surgery by fatty tissue transfer

Procedure: fatty tissue transfer
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.
No Intervention: simple supervision

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  1. 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]

  2. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Besançon Besançon France 25030
2 Clinique Saint Antoine Bois-Guillaume France 76230
3 CHU Pellegrin Bordeaux France 33076
4 Institut Bergonie Bordeaux France 33076
5 Pole de Sante de Leonard de Vinci Chambray-Les-Tours France 37145
6 Hopital Henri Mondor Créteil France 94010
7 Centre Hospitalier La Croix Rousse Lyon France 69004
8 Hopital Edouard Herriot Lyon France 69437
9 CHR Marseille Conception Marseille France 13005
10 Institut Paoli Calmettes Marseille France 13273
11 Centre Val d'Aurelle Montpellier France 34298
12 Clinique Brétéché Nantes France 44000
13 INSTITUT CURIE - Site Paris Paris France 75005
14 Hopital Saint Louis Paris France 75010
15 Centre Eugene Marquis Rennes France 35042
16 Centre Henri Becquerel Rouen France 76038
17 INSTITUT CURIE - René Huguenin Saint-Cloud France 92210
18 INSTITUT DE CANCEROLOGIE DE L'OUEST - Centre René Gauducheau Saint-Herblain France 44805
19 Hôpitaux Universitaires de Strasbourg Strasbourg France 67091
20 CHU Rangueil Toulouse France 31000
21 Institut Claudius Regaud Toulouse France 31059
22 Centre Alexis Vautrin Vandoeuvre-lès-Nancy France 54511
23 Institut Gustave Roussy Villejuif France 94805

Sponsors and Collaborators

  • Institut Claudius Regaud

Investigators

  • Principal Investigator: Ignacio GARRIDO, MD, Institut Claudius Regaud

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut Claudius Regaud
ClinicalTrials.gov Identifier:
NCT01035268
Other Study ID Numbers:
  • 08 SEIN 08
First Posted:
Dec 18, 2009
Last Update Posted:
Aug 22, 2018
Last Verified:
Aug 1, 2018
Keywords provided by Institut Claudius Regaud
breast cancer treated by conservative surgery
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Aug 22, 2018