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

NCT00002851 | Unknown Phase 3

• 3 other identifiers: CDR0000065094EORTC-10925EORTC-22922
• Study Type: interventional
• Target: 4,000
• Locations: 14 countries
• Sites: 48

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.

Conditions

Breast Cancer

Keywords

stage I breast cancer; stage II breast cancer; stage IIIA breast cancer

Interventions

adjuvant therapy PROCEDURE

low-LET electron therapy RADIATION

low-LET photon therapy RADIATION

Eligibility Criteria

• Age: Up to 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (48)

Ziekenhuis Network Antwerpen Middelheim

Antwerp, 2020, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Hopital de Jolimont

Haine-Saint-Paul, 7100, Belgium

Location

Cazk Groeninghe - Campus Maria's Voorzienigheid

Kortrijk, B-8500, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Algemeen Ziekenhuis Sint-Augustinus

Wilrijk, 2610, Belgium

Location

Institute of Oncology - Clinical Center University of Sarajevo

Sarajevo, 71000, Bosnia and Herzegovina

Location

Instituto de Radiomedicina

Santiago, 10, Chile

Location

Clinica Alemana

Santiago, 5951, Chile

Location

CHR de Besancon - Hopital Jean Minjoz

Besançon, 25030, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre de Lutte Contre le Cancer Georges-Francois Leclerc

Dijon, 21079, France

Location

CHU de Grenoble - Hopital de la Tronche

Grenoble, 38043, France

Location

Service Cancerologie Polyclinique Clairval

Marseille, 13009, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

Centre Hospitalier Universitaire Henri Mondor

Strasbourg, 67085, France

Location

Centre Leon Berard

Strasbourg, 67085, France

Location

Centre Paul Strauss

Strasbourg, 67085, France

Location

Institut Gustave Roussy

Strasbourg, 67085, France

Location

Charite - Campus Charite Mitte

Berlin, D-10117, Germany

Location

Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch

Berlin, D-13122, Germany

Location

Klinik I fuer Innere Medizin

Cologne, D-50924, Germany

Location

University of Erlangen-Nuremberg

Erlangen, DOH-91054, Germany

Location

Universitaetsklinikum Essen

Essen, D-45122, Germany

Location

Universitaetsklinikum Goettingen

Göttingen, D-37075, Germany

Location

Universitaetsklinikum Tuebingen

Tübingen, D-72076, Germany

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Chaim Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Ospedale Sant Anna

Como, 22100, Italy

Location

Istituto Nazionale per la Ricerca sul Cancro

Genoa (Genova), 16132, Italy

Location

Medisch Centrum Haaglanden

's-Gravenhage (Den Haag, the Hague), 2501 CK, Netherlands

Location

Academisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Location

Streekziekenhuis Gooi-Noord

Blaricum, 1261 AN, Netherlands

Location

Radiotherapeutisch Instituut-(Riso)

Deventer, 7400 AC, Netherlands

Location

Medisch Spectrum Twente

Enschede, 7500 KA, Netherlands

Location

Academisch Ziekenhuis Groningen

Groningen, 9713 GZ, Netherlands

Location

Radiotherapeutisch Instituut Limburg-Maastricht

Maastricht, NL-6229 ET, Netherlands

Location

Dr. Bernard Verbeeten Instituut

Tilburg, 5042 SB, Netherlands

Location

Academisch Ziekenhuis Utrecht

Utrecht, 3584 CX, Netherlands

Location

Medical University of Gdansk

Gdansk, 80-211, Poland

Location

Instituto Portugues de Oncologia Centro do Porto, SA

Porto, 4200-072, Portugal

Location

Institut Catala D'Oncologia

Barcelona, 08907, Spain

Location

Hopital Cantonal Universitaire de Geneve

Geneva, CH-1211, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

UniversitaetsSpital

Zurich, CH-8091, Switzerland

Location

Istanbul University-Institute of Oncology

Istanbul, 34390, Turkey (Türkiye)

Location

Nottingham City Hospital NHS Trust

Nottingham, England, NG5 1PB, United Kingdom

Location

Related Publications (11)

• 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.

  PMID: 20100142 RESULT

• 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.

  PMID: 17240136 RESULT

• 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.

  PMID: 17013570 RESULT

• 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.

  PMID: 12957458 RESULT

• 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.

  PMID: 11286848 RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  PMID: 35568284 DERIVED

• 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.

  PMID: 34320651 DERIVED

• 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.

  PMID: 33152277 DERIVED

• 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.

  PMID: 26200978 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Walter F. Van den Bogaert, MD, PhD

  University Hospital, Gasthuisberg

• H. Struikmans, MD, PhD

  Medisch Centrum Haaglanden Westeinde

• Alain Fourquet, MD

  Institut Curie

• Harry Bartelink, MD, PhD

  The Netherlands Cancer Institute

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: July 1, 1996
• Last Updated: January 29, 2010

Record last verified: 2004-12

Locations

BE (6); DE (7); NL (9); ES (1); IT (2); FR (11); PL (1); CL (2); IL (2); PT (1); GB (1); CH (3); BO (1); TU (1)