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

Sponsor:	European Organization for Research and Treatment of Cancer
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002851

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized
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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Surgery

U.S. FDA Resources

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

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

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Locations

Belgium
Algemeen Ziekenhuis Sint-Augustinus
Wilrijk, Belgium, 2610
Cazk Groeninghe - Campus Maria's Voorzienigheid
Kortrijk, Belgium, B-8500
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Ziekenhuis Network Antwerpen Middelheim
Antwerp, Belgium, 2020
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Hopital de Jolimont
Haine Saint Paul, Belgium, 7100
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
Centre Antoine Lacassagne
Nice, France, 06189
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, France, 21079
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
CHR de Besancon - Hopital Jean Minjoz
Besancon, France, 25030
CHU de Grenoble - Hopital de la Tronche
Grenoble, France, 38043
Institut Bergonie
Bordeaux, France, 33076
Institut Gustave Roussy
Strasbourg, France, 67085
Service Cancerologie Polyclinique Clairval
Marseille, France, 13009
Germany
Charite - Campus Charite Mitte
Berlin, Germany, D-10117
Klinik I fuer Innere Medizin
Cologne, Germany, D-50924
Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
Berlin, Germany, D-13122
Universitaetsklinikum Essen
Essen, Germany, D-45122
Universitaetsklinikum Goettingen
Goettingen, Germany, D-37075
Universitaetsklinikum Tuebingen
Tuebingen, Germany, D-72076
University of Erlangen-Nuremberg
Erlangen, Germany, DOH-91054
Israel
Chaim Sheba Medical Center
Ramat-Gan, Israel, 52621
Rambam Medical Center
Haifa, Israel, 31096
Italy
Istituto Nazionale per la Ricerca sul Cancro
Genoa (Genova), Italy, 16132
Ospedale Sant Anna
Como, Italy, 22100
Netherlands
Academisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ
Academisch Ziekenhuis Groningen
Groningen, Netherlands, 9713 GZ
Academisch Ziekenhuis Utrecht
Utrecht, Netherlands, 3584 CX
Dr. Bernard Verbeeten Instituut
Tilburg, Netherlands, 5042 SB
Medisch Centrum Haaglanden
's-Gravenhage (Den Haag, The Hague), Netherlands, 2501 CK
Medisch Spectrum Twente
Enschede, Netherlands, 7500 KA
Radiotherapeutisch Instituut Limburg-Maastricht
Maastricht, Netherlands, NL-6229 ET
Radiotherapeutisch Instituut-(Riso)
Deventer, Netherlands, 7400 AC
Streekziekenhuis Gooi-Noord
Blaricum, Netherlands, 1261 AN
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
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
Hopital Cantonal Universitaire de Geneve
Geneva, Switzerland, CH-1211
UniversitaetsSpital
Zurich, Switzerland, CH-8091
Turkey
Istanbul University-Institute of Oncology
Istanbul, Turkey, 34390
United Kingdom, England
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom, NG5 1PB

Sponsors and Collaborators

European Organization for Research and Treatment of Cancer

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 Hopital
Investigator:	Harry Bartelink, MD, PhD	Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Musat E, Poortmans P, den Bogaert WV, Struikmans H, Fourquet A, Bartelink H, Kirkove C, Budach V, Pierart M, Collette L. Quality assurance in breast cancer: EORTC experiences in the phase III trial on irradiation of the internal mammary nodes. Eur J Cancer. 2007 Mar;43(4):718-24. Epub 2007 Jan 19.

Poortmans P, Kouloulias V, van Tienhoven G, Collette L, Struikmans H, Venselaar JL, Van den Bogaert W, Davis JB, Lambin P; EORTC Radiation Oncology and Breast Cancer Groups. Quality assurance in the EORTC randomized trial 22922/10925 investigating the role of irradiation of the internal mammary and medial supraclavicular lymph node chain works. Strahlenther Onkol. 2006 Oct;182(10):576-82.

Poortmans P, Kouloulias VE, Venselaar JL, Struikmans H, Davis JB, Huyskens D, van Tienhoven G, Hurkmans C, Mijnheer B, Van den Bogaert W. Quality assurance of EORTC trial 22922/10925 investigating the role of internal mammary--medial supraclavicular irradiation in stage I-III breast cancer: the individual case review. Eur J Cancer. 2003 Sep;39(14):2035-42.

Poortmans PM, Venselaar JL, Struikmans H, Hurkmans CW, Davis JB, Huyskens D, van Tienhoven G, Vlaun V, Lagendijk JJ, Mijnheer BJ, De Winter KA, Van der Hulst MH, Van den Bogaert WF. The potential impact of treatment variations on the results of radiotherapy of the internal mammary lymph node chain: a quality-assurance report on the dummy run of EORTC Phase III randomized trial 22922/10925 in Stage I--III breast cancer(1). Int J Radiat Oncol Biol Phys. 2001 Apr 1;49(5):1399-408.

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.

Study ID Numbers:	CDR0000065094, EORTC-10925, EORTC-22922
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00002851 History of Changes
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:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on November 25, 2009