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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2004 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002851
First received: November 1, 1999
Last updated: January 28, 2010
Last verified: December 2004
  Purpose

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 Intervention Phase
Breast Cancer
Procedure: adjuvant therapy
Radiation: low-LET electron therapy
Radiation: low-LET photon therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: PHASE III RANDOMISED TRIAL INVESTIGATING THE ROLE OF INTERNAL MAMMARY AND MEDIAL SUPRACLAVICULAR (IM-MS) LYMPH NODE CHAIN IRRADIATION IN STAGE I-III BREAST CANCER

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 4000
Study Start Date: July 1996
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 75 and under

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Cardiovascular:

  • No prior cardiac disease

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • See Disease Characteristics

Other:

  • Concurrent enrollment in other randomized trials allowed
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002851

  Hide Study Locations
Locations
Belgium
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
Chile
Clinica Alemana
Santiago, Chile, 5951
Instituto de Radiomedicina
Santiago, Chile, 10
France
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 Paul Strauss
Strasbourg, France, 67085
Centre Leon Berard
Strasbourg, France, 67085
Centre Hospitalier Universitaire Henri Mondor
Strasbourg, France, 67085
Institut Gustave Roussy
Strasbourg, France, 67085
Germany
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
Israel
Rambam Medical Center
Haifa, Israel, 31096
Chaim Sheba Medical Center
Ramat-Gan, Israel, 52621
Italy
Ospedale Sant Anna
Como, Italy, 22100
Istituto Nazionale per la Ricerca sul Cancro
Genoa (Genova), Italy, 16132
Netherlands
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
Poland
Medical University of Gdansk
Gdansk, Poland, 80-211
Portugal
Instituto Portugues de Oncologia Centro do Porto, SA
Porto, Portugal, 4200-072
Spain
Institut Catala D'Oncologia
Barcelona, Spain, 08907
Switzerland
Hopital Cantonal Universitaire de Geneve
Geneva, Switzerland, CH-1211
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
UniversitaetsSpital
Zurich, Switzerland, CH-8091
Turkey
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
Investigators
Investigator: Walter F. Van den Bogaert, MD, PhD U.Z. Gasthuisberg
Investigator: H. Struikmans, MD, PhD Medisch Centrum Haaglanden Westeinde
Investigator: Alain Fourquet, MD Institut Curie
Investigator: Harry Bartelink, MD, PhD The Netherlands Cancer Institute
  More Information

Additional Information:
Publications:
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.

ClinicalTrials.gov Identifier: NCT00002851     History of Changes
Other Study ID Numbers: CDR0000065094, EORTC-10925, EORTC-22922
Study First Received: November 1, 1999
Last Updated: January 28, 2010
Health Authority: United States: Federal Government

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
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 25, 2014