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

Civil Hospices of Lyon

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Procedure: Sentinel Node Resection; Procedure: Conventional Axillary Dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT00144898

2003.312

Details and patient eligibility

About

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.

Enrollment: 1,627 patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,627 participants in 2 patient groups

Sentinel Node Resection

Experimental group

Description:

Sentinel Node Resection

Treatment:

Procedure: Sentinel Node Resection

Conventional Axillary Dissection

Other group

Description:

Conventional Axillary Dissection

Treatment:

Procedure: Conventional Axillary Dissection