search
Back to results

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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
adjuvant therapy
low-LET electron therapy
low-LET photon therapy
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage I breast cancer, stage II breast cancer, stage IIIA breast cancer

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ziekenhuis Network Antwerpen Middelheim
  • Cliniques Universitaires Saint-Luc
  • Hopital de Jolimont
  • Cazk Groeninghe - Campus Maria's Voorzienigheid
  • U.Z. Gasthuisberg
  • Algemeen Ziekenhuis Sint-Augustinus
  • Institute of Oncology - Clinical Center University of Sarajevo
  • Instituto de Radiomedicina
  • Clinica Alemana
  • CHR de Besancon - Hopital Jean Minjoz
  • Institut Bergonie
  • Centre de Lutte Contre le Cancer Georges-Francois Leclerc
  • CHU de Grenoble - Hopital de la Tronche
  • Service Cancerologie Polyclinique Clairval
  • Centre Antoine Lacassagne
  • Centre Eugene Marquis
  • Centre Hospitalier Universitaire Henri Mondor
  • Centre Leon Berard
  • Centre Paul Strauss
  • Institut Gustave Roussy
  • Charite - Campus Charite Mitte
  • Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
  • Klinik I fuer Innere Medizin
  • University of Erlangen-Nuremberg
  • Universitaetsklinikum Essen
  • Universitaetsklinikum Goettingen
  • Universitaetsklinikum Tuebingen
  • Rambam Medical Center
  • Chaim Sheba Medical Center
  • Ospedale Sant Anna
  • Istituto Nazionale per la Ricerca sul Cancro
  • Medisch Centrum Haaglanden
  • Academisch Medisch Centrum
  • Streekziekenhuis Gooi-Noord
  • Radiotherapeutisch Instituut-(Riso)
  • Medisch Spectrum Twente
  • Academisch Ziekenhuis Groningen
  • Radiotherapeutisch Instituut Limburg-Maastricht
  • Dr. Bernard Verbeeten Instituut
  • Academisch Ziekenhuis Utrecht
  • Medical University of Gdansk
  • Instituto Portugues de Oncologia Centro do Porto, SA
  • Institut Catala D'Oncologia
  • Hopital Cantonal Universitaire de Geneve
  • Centre Hospitalier Universitaire Vaudois
  • UniversitaetsSpital
  • Istanbul University-Institute of Oncology
  • Nottingham City Hospital NHS Trust

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
January 28, 2010
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
search

1. Study Identification

Unique Protocol Identification Number
NCT00002851
Brief Title
Lymph Node Radiation Therapy in Patients With Stage I, Stage II, or Stage III Breast Cancer That Has Been Surgically Removed
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2004
Overall Recruitment Status
Unknown status
Study Start Date
July 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage I breast cancer, stage II breast cancer, stage IIIA breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
4000 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Radiation
Intervention Name(s)
low-LET electron therapy
Intervention Type
Radiation
Intervention Name(s)
low-LET photon therapy

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter F. Van den Bogaert, MD, PhD
Organizational Affiliation
University Hospital, Gasthuisberg
First Name & Middle Initial & Last Name & Degree
H. Struikmans, MD, PhD
Organizational Affiliation
Medisch Centrum Haaglanden Westeinde
First Name & Middle Initial & Last Name & Degree
Alain Fourquet, MD
Organizational Affiliation
Institut Curie
First Name & Middle Initial & Last Name & Degree
Harry Bartelink, MD, PhD
Organizational Affiliation
The Netherlands Cancer Institute
Facility Information:
Facility Name
Ziekenhuis Network Antwerpen Middelheim
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Hopital de Jolimont
City
Haine Saint Paul
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Cazk Groeninghe - Campus Maria's Voorzienigheid
City
Kortrijk
ZIP/Postal Code
B-8500
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Algemeen Ziekenhuis Sint-Augustinus
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Institute of Oncology - Clinical Center University of Sarajevo
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
Instituto de Radiomedicina
City
Santiago
ZIP/Postal Code
10
Country
Chile
Facility Name
Clinica Alemana
City
Santiago
ZIP/Postal Code
5951
Country
Chile
Facility Name
CHR de Besancon - Hopital Jean Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
CHU de Grenoble - Hopital de la Tronche
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Service Cancerologie Polyclinique Clairval
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Centre Hospitalier Universitaire Henri Mondor
City
Strasbourg
ZIP/Postal Code
67085
Country
France
Facility Name
Centre Leon Berard
City
Strasbourg
ZIP/Postal Code
67085
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67085
Country
France
Facility Name
Institut Gustave Roussy
City
Strasbourg
ZIP/Postal Code
67085
Country
France
Facility Name
Charite - Campus Charite Mitte
City
Berlin
ZIP/Postal Code
D-10117
Country
Germany
Facility Name
Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
City
Berlin
ZIP/Postal Code
D-13122
Country
Germany
Facility Name
Klinik I fuer Innere Medizin
City
Cologne
ZIP/Postal Code
D-50924
Country
Germany
Facility Name
University of Erlangen-Nuremberg
City
Erlangen
ZIP/Postal Code
DOH-91054
Country
Germany
Facility Name
Universitaetsklinikum Essen
City
Essen
ZIP/Postal Code
D-45122
Country
Germany
Facility Name
Universitaetsklinikum Goettingen
City
Goettingen
ZIP/Postal Code
D-37075
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
D-72076
Country
Germany
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Ramat-Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Ospedale Sant Anna
City
Como
ZIP/Postal Code
22100
Country
Italy
Facility Name
Istituto Nazionale per la Ricerca sul Cancro
City
Genoa (Genova)
ZIP/Postal Code
16132
Country
Italy
Facility Name
Medisch Centrum Haaglanden
City
's-Gravenhage (Den Haag, the Hague)
ZIP/Postal Code
2501 CK
Country
Netherlands
Facility Name
Academisch Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Streekziekenhuis Gooi-Noord
City
Blaricum
ZIP/Postal Code
1261 AN
Country
Netherlands
Facility Name
Radiotherapeutisch Instituut-(Riso)
City
Deventer
ZIP/Postal Code
7400 AC
Country
Netherlands
Facility Name
Medisch Spectrum Twente
City
Enschede
ZIP/Postal Code
7500 KA
Country
Netherlands
Facility Name
Academisch Ziekenhuis Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Radiotherapeutisch Instituut Limburg-Maastricht
City
Maastricht
ZIP/Postal Code
NL-6229 ET
Country
Netherlands
Facility Name
Dr. Bernard Verbeeten Instituut
City
Tilburg
ZIP/Postal Code
5042 SB
Country
Netherlands
Facility Name
Academisch Ziekenhuis Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Medical University of Gdansk
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
Instituto Portugues de Oncologia Centro do Porto, SA
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Institut Catala D'Oncologia
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hopital Cantonal Universitaire de Geneve
City
Geneva
ZIP/Postal Code
CH-1211
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland
Facility Name
UniversitaetsSpital
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland
Facility Name
Istanbul University-Institute of Oncology
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
Facility Name
Nottingham City Hospital NHS Trust
City
Nottingham
State/Province
England
ZIP/Postal Code
NG5 1PB
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
20100142
Citation
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.
Results Reference
result
PubMed Identifier
17240136
Citation
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.
Results Reference
result
PubMed Identifier
17013570
Citation
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.
Results Reference
result
PubMed Identifier
12957458
Citation
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.
Results Reference
result
PubMed Identifier
11286848
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
PubMed Identifier
35568284
Citation
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.
Results Reference
derived
PubMed Identifier
34320651
Citation
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.
Results Reference
derived
PubMed Identifier
33152277
Citation
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. Erratum In: Lancet Oncol. 2021 Jan;22(1):e5.
Results Reference
derived
PubMed Identifier
26200978
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs