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

Civil Hospices of Lyon logo

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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