NCT00144898CompletedPhase 3
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
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 1,627
- Locations
- 1
- Primary Endpoint
- Survival without recurrence
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- 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.
Exclusion Criteria
- Not provided
Arms & Interventions
Sentinel Node Resection
Experimental
Sentinel Node Resection
Intervention: Sentinel Node Resection (Procedure)
Conventional Axillary Dissection
Other
Conventional Axillary Dissection
Intervention: Conventional Axillary Dissection (Procedure)
Outcomes
Primary Outcomes
Survival without recurrence
Time Frame: 5 years
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Surgical Trial to Evaluate the Impact of a Lymphoscintigraphy Prior to Sentinel Node Biopsy in Early Breast CancerEarly-Stage Breast CarcinomaNCT02481128Kliniken Essen-Mitte1,198
Completed
Phase 3
Study Assessing The Interest of Indocyanine Green Fluorescence Imaging With Radioisotope Method For Sentinel Lymph Node Biopsy in Patients With Breast CancerBreast NeoplasmsNCT02279108Centre Hospitalier Universitaire de Saint Etienne99
Terminated
Phase 2
Sentinel Node Biopsy and Axillary Sampling in Operable Breast CancerCancer of the BreastNCT00128362Tata Memorial Hospital478
Unknown
Not Applicable
Comparison Study of Different Tumor Biopsy Method for Sentinel Lymph Node Biopsy in Breast CancerSentinel Lymph NodeBreast CancerNCT04568941Shandong Cancer Hospital and Institute600
Completed
Not Applicable
Axillary surgery trial for breast cancerMalignant neoplasm of the breastCancerBreast cancerISRCTN88463711K Co-ordinating Committee for Cancer Research (UKCCCR)