Lymph Node Radiation Therapy in Patients With Stage I, Stage II, or Stage III Breast Cancer That Has Been Surgically Removed
NCT ID: NCT00002851
Last Updated: 2010-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
4000 participants
INTERVENTIONAL
1996-07-31
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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adjuvant therapy
low-LET electron therapy
low-LET photon therapy
Eligibility Criteria
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Inclusion Criteria
* 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
75 Years
FEMALE
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Principal Investigators
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Walter F. Van den Bogaert, MD, PhD
Role:
University Hospital, Gasthuisberg
H. Struikmans, MD, PhD
Role:
Medisch Centrum Haaglanden Westeinde
Alain Fourquet, MD
Role:
Institut Curie
Harry Bartelink, MD, PhD
Role:
The Netherlands Cancer Institute
Locations
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Ziekenhuis Network Antwerpen Middelheim
Antwerp, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Hopital de Jolimont
Haine-Saint-Paul, , Belgium
Cazk Groeninghe - Campus Maria's Voorzienigheid
Kortrijk, , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
Algemeen Ziekenhuis Sint-Augustinus
Wilrijk, , Belgium
Institute of Oncology - Clinical Center University of Sarajevo
Sarajevo, , Bosnia and Herzegovina
Instituto de Radiomedicina
Santiago, , Chile
Clinica Alemana
Santiago, , Chile
CHR de Besancon - Hopital Jean Minjoz
Besançon, , France
Institut Bergonie
Bordeaux, , France
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, , France
CHU de Grenoble - Hopital de la Tronche
Grenoble, , France
Service Cancerologie Polyclinique Clairval
Marseille, , France
Centre Antoine Lacassagne
Nice, , France
Centre Eugene Marquis
Rennes, , France
Centre Hospitalier Universitaire Henri Mondor
Strasbourg, , France
Centre Leon Berard
Strasbourg, , France
Centre Paul Strauss
Strasbourg, , France
Institut Gustave Roussy
Strasbourg, , France
Charite - Campus Charite Mitte
Berlin, , Germany
Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
Berlin, , Germany
Klinik I fuer Innere Medizin
Cologne, , Germany
University of Erlangen-Nuremberg
Erlangen, , Germany
Universitaetsklinikum Essen
Essen, , Germany
Universitaetsklinikum Goettingen
Göttingen, , Germany
Universitaetsklinikum Tuebingen
Tübingen, , Germany
Rambam Medical Center
Haifa, , Israel
Chaim Sheba Medical Center
Ramat Gan, , Israel
Ospedale Sant Anna
Como, , Italy
Istituto Nazionale per la Ricerca sul Cancro
Genoa (Genova), , Italy
Medisch Centrum Haaglanden
's-Gravenhage (Den Haag, the Hague), , Netherlands
Academisch Medisch Centrum
Amsterdam, , Netherlands
Streekziekenhuis Gooi-Noord
Blaricum, , Netherlands
Radiotherapeutisch Instituut-(Riso)
Deventer, , Netherlands
Medisch Spectrum Twente
Enschede, , Netherlands
Academisch Ziekenhuis Groningen
Groningen, , Netherlands
Radiotherapeutisch Instituut Limburg-Maastricht
Maastricht, , Netherlands
Dr. Bernard Verbeeten Instituut
Tilburg, , Netherlands
Academisch Ziekenhuis Utrecht
Utrecht, , Netherlands
Medical University of Gdansk
Gdansk, , Poland
Instituto Portugues de Oncologia Centro do Porto, SA
Porto, , Portugal
Institut Catala D'Oncologia
Barcelona, , Spain
Hopital Cantonal Universitaire de Geneve
Geneva, , Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
UniversitaetsSpital
Zurich, , Switzerland
Istanbul University-Institute of Oncology
Istanbul, , Turkey (Türkiye)
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom
Countries
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References
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Matzinger O, Heimsoth I, Poortmans P, Collette L, Struikmans H, Van Den Bogaert W, Fourquet A, Bartelink H, Ataman F, Gulyban A, Pierart M, Van Tienhoven G; EORTC Radiation Oncology & Breast Cancer Groups. Toxicity at three years with and without irradiation of the internal mammary and medial supraclavicular lymph node chain in stage I to III breast cancer (EORTC trial 22922/10925). Acta Oncol. 2010;49(1):24-34. doi: 10.3109/02841860903352959.
Musat E, Poortmans P, Van den Bogaert W, 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. doi: 10.1016/j.ejca.2006.11.015. 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. doi: 10.1007/s00066-006-1629-2.
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. doi: 10.1016/s0959-8049(03)00455-6.
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. doi: 10.1016/s0360-3016(00)01549-2.
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.
Kaidar-Person O, Fortpied C, Hol S, Weltens C, Kirkove C, Budach V, Peignaux-Casasnovas K, van der Leij F, Vonk E, Valli M, Weidner N, Guckenberger M, Koiter E, Fourquet A, Bartelink H, Struikmans H, Poortmans P; EORTC Radiation Oncology and Breast Cancer Groups. The association of internal mammary and medial supraclavicular lymph node radiation technique with clinical outcomes: Results from the EORTC 22922/10925 randomised trial. Radiother Oncol. 2022 Jul;172:99-110. doi: 10.1016/j.radonc.2022.05.006. Epub 2022 May 12.
Poortmans PM, Struikmans H, De Brouwer P, Weltens C, Fortpied C, Kirkove C, Budach V, Peignaux-Casasnovas K, van der Leij F, Vonk E, Valli M, vanTienhoven G, Weidner N, Noel G, Guckenberger M, Koiter E, vanLimbergen E, Engelen A, Fourquet A, Bartelink H; EORTC Radiation Oncology and Breast Cancer Groups. Side Effects 15 Years After Lymph Node Irradiation in Breast Cancer: Randomized EORTC Trial 22922/10925. J Natl Cancer Inst. 2021 Oct 1;113(10):1360-1368. doi: 10.1093/jnci/djab113.
Poortmans PM, Weltens C, Fortpied C, Kirkove C, Peignaux-Casasnovas K, Budach V, van der Leij F, Vonk E, Weidner N, Rivera S, van Tienhoven G, Fourquet A, Noel G, Valli M, Guckenberger M, Koiter E, Racadot S, Abdah-Bortnyak R, Van Limbergen EF, Engelen A, De Brouwer P, Struikmans H, Bartelink H; European Organisation for Research and Treatment of Cancer Radiation Oncology and Breast Cancer Groups. Internal mammary and medial supraclavicular lymph node chain irradiation in stage I-III breast cancer (EORTC 22922/10925): 15-year results of a randomised, phase 3 trial. Lancet Oncol. 2020 Dec;21(12):1602-1610. doi: 10.1016/S1470-2045(20)30472-1. Epub 2020 Nov 2.
Poortmans PM, Collette S, Kirkove C, Van Limbergen E, Budach V, Struikmans H, Collette L, Fourquet A, Maingon P, Valli M, De Winter K, Marnitz S, Barillot I, Scandolaro L, Vonk E, Rodenhuis C, Marsiglia H, Weidner N, van Tienhoven G, Glanzmann C, Kuten A, Arriagada R, Bartelink H, Van den Bogaert W; EORTC Radiation Oncology and Breast Cancer Groups. Internal Mammary and Medial Supraclavicular Irradiation in Breast Cancer. N Engl J Med. 2015 Jul 23;373(4):317-27. doi: 10.1056/NEJMoa1415369.
Other Identifiers
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EORTC-10925
Identifier Type: -
Identifier Source: secondary_id
EORTC-22922
Identifier Type: -
Identifier Source: secondary_id
CDR0000065094
Identifier Type: -
Identifier Source: org_study_id