Comparison of Complete Axillary Lymph Node Dissection With Axillary Radiation Therapy in Treating Women With Invasive Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Procedure: axillary lymph node dissectionProcedure: lymphoscintigraphyProcedure: therapeutic conventional surgeryRadiation: radiation therapy
- Registration Number
- NCT00014612
- Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be a less invasive treatment and cause fewer side effects than complete axillary lymph node dissection. It is not yet known which treatment is more effective for invasive breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of complete axillary lymph node dissection with that of axillary radiation therapy in treating women who have invasive breast cancer.
- Detailed Description
OBJECTIVES:
* Compare the regional control of the axilla obtained by complete axillary lymph node dissection vs axillary radiotherapy in sentinel lymph node-positive women with operable invasive breast cancer.
* Determine whether local and regional axillary control can be obtained without axillary lymph node dissection in sentinel lymph node-negative women.
* Compare the axillary 5-year recurrence-free survival of these patients treated with these regimens.
* Compare the morbidity of patients treated with these regimens.
* Compare the quality of life of these patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and type of breast surgery (conservation vs total mastectomy). Patients are randomized to 1 of 2 treatment arms.
Patients are given an injection of a tracer and undergo lymphoscintigraphy 2-3 hours later to identify the sentinel lymph node. Within 24 hours after lymphoscintigraphy, patients undergo wide local excision of the tumor or mastectomy after the sentinel node is removed. If no sentinel node is found or metastasis is found in a nonsentinel node, patients undergo complete axillary lymph node dissection (ALND) regardless of randomization. Sentinel node-negative patients receive no further treatment. Sentinel node-positive patients continue treatment according to randomization.
* Arm I: Within 8 weeks after surgery, patients undergo complete ALND.
* Arm II: Within 8 weeks after surgery, patients undergo axillary lymph node radiotherapy daily 5 days a week for 5 weeks.
Patients in arm I may receive postoperative axillary irradiation if 4 or more nodes are positive and more than 1 axillary level is involved.
Quality of life is assessed at baseline and then at 1, 2, 3, and 5 years.
Patients are followed annually for 5 years.
PROJECTED ACCRUAL: A total of 3,485 patients (1,394 sentinel node-positive and 2,091 sentinel node-negative) will be accrued for this study within 3 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 4813
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description axillary lymph node dissection axillary lymph node dissection complete axillary lymph node dissection axillary lymph node dissection lymphoscintigraphy complete axillary lymph node dissection axillary lymph node dissection therapeutic conventional surgery complete axillary lymph node dissection axillary radiotherapy lymphoscintigraphy axillary radiotherapy, daily for 5 days a week, for 5 weeks axillary radiotherapy therapeutic conventional surgery axillary radiotherapy, daily for 5 days a week, for 5 weeks axillary radiotherapy radiation therapy axillary radiotherapy, daily for 5 days a week, for 5 weeks
- Primary Outcome Measures
Name Time Method Axillary recurrence rate from randomization
- Secondary Outcome Measures
Name Time Method Disease-free survival from randomization Overall survival from randomization Shoulder function as assessed by arm function test questionnaire at baseline, 1, 3, and 5 years after surgery from randomization Quality of life as measured by Quality of Life Questionnaire Core 30 Items (QLQ-C30) and QLQ-BR25 at baseline, 1, 2, 3, and 5 years after surgery from randomization Axillary recurrence-free survival from randomization
Trial Locations
- Locations (29)
NIJ Smellinghe
🇳🇱Drachten, Netherlands
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
🇳🇱Amsterdam, Netherlands
CHU de Grenoble - Hopital de la Tronche
🇫🇷Grenoble, France
Centre Oscar Lambret
🇫🇷Lille, France
Kennemer Gasthuis - Locatie EG
🇳🇱Haarlem, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
🇮🇹Turin, Italy
HagaZiekenhuis - Locatie Leyenburg
🇳🇱's-Gravenhage, Netherlands
Gelre Ziekenhuizen - Lokatie Lukas
🇳🇱Apeldoorn, Netherlands
HagaZiekenhuis - Locatie Rode Kruis
🇳🇱Den Haag, Netherlands
Ropcke-Zweers Ziekenhuis
🇳🇱Hardenberg, Netherlands
Universita Degli Studi di Florence - Policlinico di Careggi
🇮🇹Firenze (Florence), Italy
Wythenshawe Hospital
🇬🇧Manchester, England, United Kingdom
Ziekenhuis Amstelland
🇳🇱Amstelveen, Netherlands
Ziekenhuis St. Jansdal
🇳🇱Harderwijk, Netherlands
Universitair Medisch Centrum St. Radboud - Nijmegen
🇳🇱Nijmegen, Netherlands
Rijnstate Hospital
🇳🇱Arnhem, Netherlands
Reinier de Graaf Group - Delft
🇳🇱Delft, Netherlands
Catharina Ziekenhuis
🇳🇱Eindhoven, Netherlands
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Academisch Medisch Centrum at University of Amsterdam
🇳🇱Amsterdam, Netherlands
Ziekenhuis Bronovo
🇳🇱Den Haag, Netherlands
Saint Laurentius Ziekenhuis
🇳🇱Roermond, Netherlands
Medical University of Gdansk
🇵🇱Gdansk, Poland
Marmara University Hospital
🇹🇷Istanbul, Turkey
University Hospital of Wales
🇬🇧Cardiff, Wales, United Kingdom
Institute of Oncology - Ljubljana
🇸🇮Ljubljana, Slovenia
Hopital Cantonal Universitaire de Geneve
🇨ðŸ‡Geneva, Switzerland
University Medical Center Utrecht
🇳🇱Utrecht, Netherlands