History of Changes for Study: NCT00002851

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

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Study Record Versions

Version	Submitted Date	Changes
1	June 23, 2005	None (earliest Version on record)
2	January 5, 2007	Recruitment Status, Study Status, References, Contacts/Locations, Study Identification, Eligibility, Study Design, Conditions and Study Description
3	January 11, 2007	Recruitment Status, Study Status, References, Contacts/Locations, Study Identification, Study Design, Conditions and Study Description
4	February 8, 2007	References, Conditions, Study Status, Study Identification, Contacts/Locations, Eligibility, Study Design and Study Description
5	February 20, 2007	Eligibility and Study Status
6	March 5, 2007	Contacts/Locations and Study Status
7	March 20, 2007	References and Study Status
8	May 16, 2007	Study Design and Study Status
9	October 26, 2007	Arms and Interventions and Study Status
10	November 16, 2007	Study Status
11	December 15, 2007	Study Status
12	July 23, 2008	Study Design and Study Status
13	February 6, 2009	Arms and Interventions and Study Status
14	January 28, 2010	Recruitment Status, Study Status, References and Contacts/Locations

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	CDR0000065094
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 Randomized Study of Internal Mammary and Medial Supraclavicular Lymph Node Chain Irradiation Vs No Further Therapy in Women With Resected Stage I/II/III Breast Cancer
Secondary IDs:	EORTC-10925 EORTC-22922 NCT00002851

Study Status


Record Verification:	February 2005
Overall Status:	Active, not recruiting
Study Start:
Primary Completion:
Study Completion:

First Submitted:	November 1, 1999
First Submitted that Met QC Criteria:	January 26, 2003
First Posted:	January 27, 2003 [Estimate]

Last Update Submitted that Met QC Criteria:	June 23, 2005
Last Update Posted:	June 24, 2005 [Estimate]

Sponsor/Collaborators


Sponsor:	European Organisation for Research and Treatment of Cancer - EORTC
Responsible Party:
Collaborators:

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:

Study Description

Brief Summary:

RATIONALE: Radiation therapy may kill any tumor cells remaining after surgery.

PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy in treating women who have 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.

Conditions


Conditions:	Stage I Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:
Number of Arms:
Masking:	(masked roles unspecified)
Enrollment:

Arms and Interventions


Intervention Details:
	Procedure: adjuvant therapy
	Procedure: low-LET electron therapy
	Procedure: low-LET photon therapy
	Procedure: radiation therapy

Eligibility


Minimum Age:	0 Years
Maximum Age:	75 Years
Sex:	All
Gender Based:
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/Locations


Study Officials:	Walter F. Van den Bogaert, MD, PhD University Hospital, Gasthuisberg
	H. Struikmans, MD, PhD Medical Center Haaglanden
	Alain Fourquet, MD Institut Curie - Section Medicale
	Harry Bartelink, MD, PhD The Netherlands Cancer Institute
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
	Instituto de Radiomedicina Santiago, Chile, 10
	Clinica Alemana Santiago, Chile, 5951
	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 Hospitalier Universitaire Henri Mondor Strasbourg, France, 67085
	Centre Leon Berard Strasbourg, France, 67085
	Centre Paul Strauss 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, England
	Nottingham City Hospital NHS Trust Nottingham, England, United Kingdom, NG5 1PB

IPDSharing


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References


Citations:	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. PubMed 12957458
	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. PubMed 11286848
	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.
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