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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1627 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sentinel Node Resection

Group Type EXPERIMENTAL

Sentinel Node Resection

Intervention Type PROCEDURE

Sentinel Node Resection

Conventional Axillary Dissection

Group Type OTHER

Conventional Axillary Dissection

Intervention Type PROCEDURE

Conventional Axillary Dissection

Interventions

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Sentinel Node Resection

Intervention Type PROCEDURE

Conventional Axillary Dissection

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No