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

NCT00014612 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4813

Last updated 2013-10-29

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

axillary lymph node dissection

PROCEDURE

lymphoscintigraphy

PROCEDURE

therapeutic conventional surgery

RADIATION

radiation therapy

Sponsors & Collaborators

  • ALMANAC Trialists Group

    collaborator UNKNOWN

  • Borstkanker Onderzoeksgroup Nederland

    collaborator UNKNOWN

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Emiel JT Rutgers · The Netherlands Cancer Institute

  • Robert Mansel · Cardiff and Vale University Health Board - University Hospital of Wales, Cardiff

  • Cornelis Van De Velde · Leiden University Medical Centre, Leiden

  • Geertjan Van Tienhoven · Academisch Medisch Centrum - Universiteit van Amsterdam, Amsterdam

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-02-28
Primary Completion
2010-11-30
Completion
2013-03-31

Countries

  • France
  • Italy
  • Netherlands
  • Poland
  • Slovenia
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00014612 on ClinicalTrials.gov