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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00144898
First received: September 2, 2005
Last updated: July 22, 2011
Last verified: July 2011
History of Changes
  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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 2400
Study Start Date: July 2003
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (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
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: Alain LEIZOROVICZ, Université Claude Bernard Lyon I
ClinicalTrials.gov Identifier: NCT00144898     History of Changes
Other Study ID Numbers: 2003.312
Study First Received: September 2, 2005
Last Updated: July 22, 2011
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 May 16, 2013