Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT00002851
Status:
UNKNOWN
Last Update Posted:
2010-01-29
First Post:
1999-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lymph Node Radiation Therapy in Patients With Stage I, Stage II, or Stage III Breast Cancer That Has Been Surgically Removed
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '1996-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2004-12', 'lastUpdateSubmitDate': '2010-01-28', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2010-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['stage I breast cancer', 'stage II breast cancer', 'stage IIIA breast cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '20100142', 'type': 'RESULT', '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.'}, {'pmid': '17240136', 'type': 'RESULT', '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.'}, {'pmid': '17013570', 'type': 'RESULT', '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.'}, {'pmid': '12957458', 'type': 'RESULT', '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.'}, {'pmid': '11286848', 'type': 'RESULT', '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.'}, {'type': '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.'}, {'type': '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.'}, {'pmid': '35568284', 'type': 'DERIVED', '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.'}, {'pmid': '34320651', 'type': 'DERIVED', '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.'}, {'pmid': '33152277', 'type': 'DERIVED', '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.'}, {'pmid': '26200978', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Radiation therapy may kill any tumor cells remaining after surgery.\n\nPURPOSE: 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.', 'detailedDescription': 'OBJECTIVES:\n\n* 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.\n\nOUTLINE: 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.\n\n* Arm I: Patients receive no nodal irradiation.\n* 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.\n\nPatients are followed at least yearly after randomization for up to 20 years.\n\nPROJECTED ACCRUAL: A total of 4,000 patients will be accrued for this study within 4 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed unilateral adenocarcinoma of the breast\n* 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:\n\n * Centrally or medially located with any lymph node status\n\n * Central location defined as underlying the areola\n * Medial location defined as at least partial involvement of upper or lower medial quadrant of breast\n * Externally located with axillary node involvement\n* Prior mastectomy or breast-conserving surgery and axillary dissection required\n\n * Sentinel node procedure as axillary intervention without further axillary surgery is allowed\n * No prior internal mammary chain dissection\n * No upper inner lesion treated with breast-conserving surgery that precludes sparing of internal mammary lymph node chain from radiotherapy volume\n\n * Decision at radiation oncologist's discretion\n* Hormone receptor status:\n\n * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 75 and under\n\nSex:\n\n* Female\n\nMenopausal status:\n\n* Not specified\n\nPerformance status:\n\n* Not specified\n\nHematopoietic:\n\n* Not specified\n\nHepatic:\n\n* Not specified\n\nRenal:\n\n* Not specified\n\nCardiovascular:\n\n* No prior cardiac disease\n\nOther:\n\n* No prior malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* Not specified\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* Not specified\n\nSurgery:\n\n* See Disease Characteristics\n\nOther:\n\n* Concurrent enrollment in other randomized trials allowed"}, 'identificationModule': {'nctId': 'NCT00002851', 'briefTitle': 'Lymph Node Radiation Therapy in Patients With Stage I, Stage II, or Stage III Breast Cancer That Has Been Surgically Removed', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CDR0000065094'}, 'secondaryIdInfos': [{'id': 'EORTC-10925'}, {'id': 'EORTC-22922'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'adjuvant therapy', 'type': 'PROCEDURE'}, {'name': 'low-LET electron therapy', 'type': 'RADIATION'}, {'name': 'low-LET photon therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2020', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Ziekenhuis Network Antwerpen Middelheim', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques Universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '7100', 'city': 'Haine-Saint-Paul', 'country': 'Belgium', 'facility': 'Hopital de Jolimont', 'geoPoint': {'lat': 50.45544, 'lon': 4.1885}}, {'zip': 'B-8500', 'city': 'Kortrijk', 'country': 'Belgium', 'facility': "Cazk Groeninghe - Campus Maria's Voorzienigheid", 'geoPoint': {'lat': 50.82803, 'lon': 3.26487}}, {'zip': 'B-3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'U.Z. Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '2610', 'city': 'Wilrijk', 'country': 'Belgium', 'facility': 'Algemeen Ziekenhuis Sint-Augustinus', 'geoPoint': {'lat': 51.16734, 'lon': 4.39513}}, {'zip': '71000', 'city': 'Sarajevo', 'country': 'Bosnia and Herzegovina', 'facility': 'Institute of Oncology - Clinical Center University of Sarajevo', 'geoPoint': {'lat': 43.84864, 'lon': 18.35644}}, {'zip': '10', 'city': 'Santiago', 'country': 'Chile', 'facility': 'Instituto de Radiomedicina', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '5951', 'city': 'Santiago', 'country': 'Chile', 'facility': 'Clinica Alemana', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'CHR de Besancon - Hopital Jean Minjoz', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonie', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'Centre de Lutte Contre le Cancer Georges-Francois Leclerc', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU de Grenoble - 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Van den Bogaert, MD, PhD', 'affiliation': 'University Hospital, Gasthuisberg'}, {'name': 'H. Struikmans, MD, PhD', 'affiliation': 'Medisch Centrum Haaglanden Westeinde'}, {'name': 'Alain Fourquet, MD', 'affiliation': 'Institut Curie'}, {'name': 'Harry Bartelink, MD, PhD', 'affiliation': 'The Netherlands Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}}}}