Technetium Tc 99m Sulfur Colloid and Blue Dye In Detecting Sentinel Lymph Nodes in Patients With Breast Cancer
RATIONALE: It is not yet known whether injecting technetium Tc 99m sulfur colloid and blue dye near the tumor is more effective than injecting them near the nipple in identifying sentinel lymph nodes in patients with stage I or stage II breast cancer.
PURPOSE: Randomized diagnostic trial to compare the effectiveness of injecting technetium Tc 99m sulfur colloid and blue dye near the tumor with that of injections around the nipple in detecting sentinel lymph nodes in patients who have stage I or stage II breast cancer.
|Breast Cancer||Drug: patent blue V dye Procedure: radionuclide imaging Procedure: sentinel lymph node biopsy Radiation: technetium Tc 99m sulfur colloid|
|Study Design:||Allocation: Randomized
Primary Purpose: Diagnostic
|Official Title:||French Randomized Sentinel Node Multicentric Study|
|Study Start Date:||October 2002|
|Study Completion Date:||May 2007|
- Determine the optimal mode of injection (peritumoral vs periareolar) of patent blue V dye and technetium Tc 99m sulfur colloid in patients with stage I or II breast cancer undergoing sentinel lymph node identification.
- Determine the reduction of morbidity associated with breast cancer surgery, in terms of local control and survival, in patients undergoing sentinel lymph node identification with these drugs.
- Determine the evolution of disease in patients who have undergone this procedure and do not show histological invasion of the sentinel lymph node.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive peritumoral injections of patent blue V dye and technetium Tc 99m sulfur colloid.
- Arm II: Patients receive periareolar injections as in arm I. Patients in both arms showing histological metastasis of the sentinel lymph node or without identification of the sentinel lymph node undergo standard axillary lymph node dissection.
Patients are followed for disease evolution.
PROJECTED ACCRUAL: A total of 450 patients (225 per arm) will be accrued for this study within 2-2.5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052676
|Bordeaux, France, F-33030|
|Centre Jean Perrin|
|Clermont-Ferrand, France, 63011|
|Centre Leon Berard|
|Lyon, France, 69373|
|Institut J. Paoli and I. Calmettes|
|Marseille, France, 13273|
|Centre Regional Rene Gauducheau|
|Nantes-Saint Herblain, France, 44805|
|Centre Paul Strauss|
|Strasbourg, France, 67085|
|Institut Claudius Regaud|
|Strasbourg, France, 67085|
|Study Chair:||Jean-Francois Rodier, MD||Centre Paul Strauss|