GF-GS 01: Comparing Conventional Axillary Dissection Versus Sentinel Node Resection in Clinically Node-negative Operable Breast Cancer
Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Completed
CT.gov ID
NCT00144898
Collaborator
(none)
1,627
1
2
107
15.2
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1627 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date
:
Jul 1, 2003
Actual Primary Completion Date
:
Jun 1, 2012
Actual Study Completion Date
:
Jun 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sentinel Node Resection Sentinel Node Resection |
Procedure: Sentinel Node Resection
Sentinel Node Resection
|
| Other: Conventional Axillary Dissection Conventional Axillary Dissection |
Procedure: Conventional Axillary Dissection
Conventional Axillary Dissection
|
Outcome Measures
Primary Outcome Measures
- Survival without recurrence [5 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 90 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alain LEIZOROVICZ | Lyon | France | 69376 |
Sponsors and Collaborators
- Hospices Civils de Lyon
Investigators
- Principal Investigator: Gilles HOUVENAEGHEL, MD, Institut Paoli Calmette
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00144898
Other Study ID Numbers:
- 2003.312
First Posted:
Sep 5, 2005
Last Update Posted:
May 28, 2019
Last Verified:
Jul 1, 2013
Keywords provided by Hospices Civils de Lyon
Additional relevant MeSH terms: