GF-GS 01: Comparing Conventional Axillary Dissection Versus Sentinel Node Resection in Clinically Node-negative Operable Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00144898
First received: September 2, 2005
Last updated: July 26, 2013
Last verified: July 2013
  Purpose

Sentinel node resection appears as a promising advancement in the surgical treatment of breast cancer.

The GF-GS 01 study, sponsored by a National Hospital Research Program, compares this new surgical method with a classical method in patients having a negative sentinel node.

The duration of the follow-up is 5 years.


Condition Intervention Phase
Breast Cancer
Procedure: Sentinel Node Resection
Procedure: Conventional Axillary Dissection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Phase III Clinical Trial GF-GS 01 to Compare Conventional Axillary Dissection Versus Sentinel Node Resection (GS) in Clinically Node-negative Operable Breast Cancer Unifocal N0 Patients

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Survival without recurrence [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 1627
Study Start Date: July 2003
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sentinel Node Resection
Sentinel Node Resection
Procedure: Sentinel Node Resection
Sentinel Node Resection
Conventional Axillary Dissection
Conventional Axillary Dissection
Procedure: Conventional Axillary Dissection
Conventional Axillary Dissection

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women older than 18 years with clinically node-negative operable unifocal N0 breast cancer (clinical tumour size < 30 mm).
  • Written consent is obtained from all patients before randomization.
  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: NCT00144898

Locations
France
Alain LEIZOROVICZ
Lyon, France, 69376
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Gilles HOUVENAEGHEL, MD Institut Paoli Calmette
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00144898     History of Changes
Other Study ID Numbers: 2003.312
Study First Received: September 2, 2005
Last Updated: July 26, 2013
Health Authority: France: Ministry of Health

Keywords provided by Hospices Civils de Lyon:
Breast cancer
sentinel node resection
survival
Breast cancer unifocal N0

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014