Comparison of Complete Axillary Lymph Node Dissection With Axillary Radiation Therapy in Treating Women With Invasive Breast Cancer

Phase 3

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00014612
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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.

Study Timeline

• Study Start: 2001-02
• Study First Submitted: 2001-04-10
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2010-11
• Study Completion: 2013-03
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-28
• Last Update Posted: 2013-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 4813

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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)

CHU de Grenoble - Hopital de la Tronche; 🇫🇷 Grenoble, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Universita Degli Studi di Florence - Policlinico di Careggi; 🇮🇹 Firenze (Florence), Italy

Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino; 🇮🇹 Turin, Italy

HagaZiekenhuis - Locatie Leyenburg; 🇳🇱 's-Gravenhage, Netherlands

Ziekenhuis Amstelland; 🇳🇱 Amstelveen, Netherlands

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital; 🇳🇱 Amsterdam, Netherlands

Academisch Medisch Centrum at University of Amsterdam; 🇳🇱 Amsterdam, Netherlands

Gelre Ziekenhuizen - Lokatie Lukas; 🇳🇱 Apeldoorn, Netherlands

Rijnstate Hospital; 🇳🇱 Arnhem, Netherlands

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