Lymph Node Radiation Therapy in Patients With Stage I, Stage II, or Stage III Breast Cancer That Has Been Surgically Removed

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002851
Recruitment Status : Unknown
Verified December 2004 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : January 29, 2010
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Radiation therapy may kill any tumor cells remaining after surgery.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to no further therapy in treating women with stage I, stage II, or stage III breast cancer that has been surgically removed.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: adjuvant therapy Radiation: low-LET electron therapy Radiation: low-LET photon therapy Phase 3

Detailed Description:


  • Compare the effect of irradiation of the homolateral internal mammary and medial supraclavicular lymph node chains vs no further therapy on survival, disease-free survival, metastasis-free survival, and cause of death in women with resected stage I/II/III breast cancer.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating institution, tumor location, type of prior breast surgery, pathologic T and N stage, menopausal status, and time sequence of radiotherapy and adjuvant chemotherapy. Patients are randomized to 1 of 2 arms.

  • Arm I: Patients receive no nodal irradiation.
  • Arm II: Patients receive irradiation of the internal mammary and medial supraclavicular lymph node chains delivered at 1 fraction per day, 5 sessions per week, for a total of 25 fractions over 5 weeks. Radiotherapy must begin no later than 8 weeks after surgery. If adjuvant chemotherapy is given, radiotherapy begins within 6 weeks after the last course of chemotherapy and within 8 months after surgery.

Patients are followed at least yearly after randomization for up to 20 years.

PROJECTED ACCRUAL: A total of 4,000 patients will be accrued for this study within 4 years.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: Randomized
Primary Purpose: Treatment
Study Start Date : July 1996

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed unilateral adenocarcinoma of the breast
  • Stage I/II/III (Tx, T0-3, N0-2) disease in one of the following categories or multifocal tumors if one of the foci is in agreement with the following:

    • Centrally or medially located with any lymph node status

      • Central location defined as underlying the areola
      • Medial location defined as at least partial involvement of upper or lower medial quadrant of breast
    • Externally located with axillary node involvement
  • Prior mastectomy or breast-conserving surgery and axillary dissection required

    • Sentinel node procedure as axillary intervention without further axillary surgery is allowed
    • No prior internal mammary chain dissection
    • No upper inner lesion treated with breast-conserving surgery that precludes sparing of internal mammary lymph node chain from radiotherapy volume

      • Decision at radiation oncologist's discretion
  • Hormone receptor status:

    • Not specified



  • 75 and under


  • Female

Menopausal status:

  • Not specified

Performance status:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • No prior cardiac disease


  • No prior malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • Not specified


  • Not specified


  • See Disease Characteristics


  • Concurrent enrollment in other randomized trials allowed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002851

  Hide Study Locations
Ziekenhuis Network Antwerpen Middelheim
Antwerp, Belgium, 2020
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Hopital de Jolimont
Haine Saint Paul, Belgium, 7100
Cazk Groeninghe - Campus Maria's Voorzienigheid
Kortrijk, Belgium, B-8500
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Algemeen Ziekenhuis Sint-Augustinus
Wilrijk, Belgium, 2610
Bosnia and Herzegovina
Institute of Oncology - Clinical Center University of Sarajevo
Sarajevo, Bosnia and Herzegovina, 71000
Instituto de Radiomedicina
Santiago, Chile, 10
Clinica Alemana
Santiago, Chile, 5951
CHR de Besancon - Hopital Jean Minjoz
Besancon, France, 25030
Institut Bergonie
Bordeaux, France, 33076
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, France, 21079
CHU de Grenoble - Hopital de la Tronche
Grenoble, France, 38043
Service Cancerologie Polyclinique Clairval
Marseille, France, 13009
Centre Antoine Lacassagne
Nice, France, 06189
Centre Eugene Marquis
Rennes, France, 35042
Centre Hospitalier Universitaire Henri Mondor
Strasbourg, France, 67085
Centre Leon Berard
Strasbourg, France, 67085
Centre Paul Strauss
Strasbourg, France, 67085
Institut Gustave Roussy
Strasbourg, France, 67085
Charite - Campus Charite Mitte
Berlin, Germany, D-10117
Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
Berlin, Germany, D-13122
Klinik I fuer Innere Medizin
Cologne, Germany, D-50924
University of Erlangen-Nuremberg
Erlangen, Germany, DOH-91054
Universitaetsklinikum Essen
Essen, Germany, D-45122
Universitaetsklinikum Goettingen
Goettingen, Germany, D-37075
Universitaetsklinikum Tuebingen
Tuebingen, Germany, D-72076
Rambam Medical Center
Haifa, Israel, 31096
Chaim Sheba Medical Center
Ramat-Gan, Israel, 52621
Ospedale Sant Anna
Como, Italy, 22100
Istituto Nazionale per la Ricerca sul Cancro
Genoa (Genova), Italy, 16132
Medisch Centrum Haaglanden
's-Gravenhage (Den Haag, the Hague), Netherlands, 2501 CK
Academisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ
Streekziekenhuis Gooi-Noord
Blaricum, Netherlands, 1261 AN
Radiotherapeutisch Instituut-(Riso)
Deventer, Netherlands, 7400 AC
Medisch Spectrum Twente
Enschede, Netherlands, 7500 KA
Academisch Ziekenhuis Groningen
Groningen, Netherlands, 9713 GZ
Radiotherapeutisch Instituut Limburg-Maastricht
Maastricht, Netherlands, NL-6229 ET
Dr. Bernard Verbeeten Instituut
Tilburg, Netherlands, 5042 SB
Academisch Ziekenhuis Utrecht
Utrecht, Netherlands, 3584 CX
Medical University of Gdansk
Gdansk, Poland, 80-211
Instituto Portugues de Oncologia Centro do Porto, SA
Porto, Portugal, 4200-072
Institut Catala D'Oncologia
Barcelona, Spain, 08907
Hopital Cantonal Universitaire de Geneve
Geneva, Switzerland, CH-1211
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
Zurich, Switzerland, CH-8091
Istanbul University-Institute of Oncology
Istanbul, Turkey, 34390
United Kingdom
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom, NG5 1PB
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
OverallOfficial: Walter F. Van den Bogaert, MD, PhD University Hospital, Gasthuisberg
OverallOfficial: H. Struikmans, MD, PhD Medisch Centrum Haaglanden Westeinde
OverallOfficial: Alain Fourquet, MD Institut Curie
OverallOfficial: Harry Bartelink, MD, PhD The Netherlands Cancer Institute

Publications of Results:
Poortmans P, Van Den Bogaert W, Venselaar J, et al.: Quality assurance in EORTC trial 22922/10925 concerning internal mammary chain (IMC) irradiation: the dummy run. Radiother Oncol 48(suppl 1): A735, s186, 1998.
Poortmans P, Van Den Bogaert W, Venselaar J, et al.: EORTC randomized phase III trials 22922/10925 investigating the role of internal mammary chain (IMC) irradiation in stage I-II breast cancer: a quality assurance report on the dummy run. Eur J Cancer 34(suppl 5): A257, s58, 1998.

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00002851     History of Changes
Other Study ID Numbers: CDR0000065094
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 29, 2010
Last Verified: December 2004

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases