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NCT00144898 Clinical Trial

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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00144898
Other study ID # 2003.312
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date July 2003
Est. completion date June 2012

Study information
Verified date July 2013
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 1627
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 90 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Sentinel Node Resection
Sentinel Node Resection
• Conventional Axillary Dissection
Conventional Axillary Dissection

Locations
Country Name City State
France Alain LEIZOROVICZ Lyon

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

References & Publications (1)

Roy P, Leizorovicz A, Villet R, Mercier C, Bobin JY. Systematic versus sentinel-lymph-node-driven axillary-lymph-node dissection in clinically node-negative patients with operable breast cancer. Results of the GF-GS01 randomized trial. Breast Cancer Res T — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Survival without recurrence 5 years
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