Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-26 @ 11:47 PM
Study NCT ID:
NCT00002895
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Chemotherapy Based on CA 125 Level Alone Compared With Delayed Chemotherapy in Treating Patients With Recurrent Ovarian Epithelial , Fallopian Tube, or Primary Peritoneal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}], 'ancestors': [{'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1996-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-03', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Benefit of early chemotherapy'}, {'measure': 'Overall survival'}, {'measure': 'Quality of life'}]}, 'conditionsModule': {'keywords': ['recurrent ovarian epithelial cancer', 'primary peritoneal cavity cancer', 'fallopian tube cancer'], 'conditions': ['Fallopian Tube Cancer', 'Ovarian Cancer', 'Primary Peritoneal Cavity Cancer']}, 'referencesModule': {'references': [{'pmid': '20215782', 'type': 'BACKGROUND', 'citation': 'Markman M, Petersen J, Belland A, Burg K. CA-125 monitoring in ovarian cancer: patient survey responses to the results of the MRC/EORTC CA-125 Surveillance Trial. Oncology. 2010;78(1):1-2. doi: 10.1159/000292352. Epub 2010 Mar 6. No abstract available.'}, {'pmid': '20888993', 'type': 'RESULT', 'citation': 'Rustin GJ, van der Burg ME, Griffin CL, Guthrie D, Lamont A, Jayson GC, Kristensen G, Mediola C, Coens C, Qian W, Parmar MK, Swart AM; MRC OV05; EORTC 55955 investigators. Early versus delayed treatment of relapsed ovarian cancer (MRC OV05/EORTC 55955): a randomised trial. Lancet. 2010 Oct 2;376(9747):1155-63. doi: 10.1016/S0140-6736(10)61268-8.'}, {'type': 'RESULT', 'citation': 'Rustin GJ, van der Burg ME: A randomized trial in ovarian cancer (OC) of early treatment of relapse based on CA125 level alone versus delayed treatment based on conventional clinical indicators (MRC OV05/EORTC 55955 trials). [Abstract] J Clin Oncol 27 (Suppl 18): A-1, 2009.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: It is not yet known if treatment for recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer is more effective if it is begun when blood levels of CA 125 become elevated rather than waiting for other indicators of disease recurrence.\n\nPURPOSE: This randomized phase III trial is studying early chemotherapy based on blood levels of CA 125 alone to see how well it works compared to chemotherapy based on conventional clinical indicators in patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the benefit of early chemotherapy based on CA 125 level only vs chemotherapy based on conventional clinical indicators in patients with relapsed ovarian epithelial, fallopian tube, or primary peritoneal cancer.\n* Compare the overall survival of patients treated with these regimens.\n* Compare the quality of life of patients treated with these regimens.\n\nOUTLINE: This is a randomized, multicenter study. Patients whose CA 125 levels rise to more than two times the upper limit of normal are randomized to one of two treatment arms.\n\n* Arm I: The clinician is informed of the initial rise in CA 125 level. A confirmatory test is performed immediately. Within 4 weeks of the initial CA 125 elevation, patients with a second confirmed elevation receive treatment for recurrent disease according to standard local practice. Patients with a normal CA 125 on the confirmatory test receive no treatment until clinically indicated.\n* Arm II: The clinician is blinded to the CA 125 results. Patients undergo normal monitoring. When clinically indicated, patients commence treatment according to standard local practice.\n\nQuality of life is assessed at baseline, at each follow-up visit, and, if treatment is instituted, before each chemotherapy course.\n\nPatients are followed every 3 months.\n\nPROJECTED ACCRUAL: A total of 1,400 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer\n\n * Achieved complete remission with normal CA 125 after first-line platinum-containing chemotherapy\n* Prior participation in the following clinical trials is allowed:\n\n * MRC-ICON2 (carboplatin vs cyclophosphamide, doxorubicin, and cisplatin for advanced disease)\n * MRC-ICON3 (paclitaxel with carboplatin in first-line therapy for advanced disease)\n * MRC-ICON5 (carboplatin and paclitaxel vs triplet and sequential doublet combinations of chemotherapy)\n* No prior participation in MRC-ICON1 (adjuvant chemotherapy for early-stage ovarian cancer)\n\nPATIENT CHARACTERISTICS:\n\nAge:\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\nOther:\n\n* No prior or concurrent malignancy within the past 5 years that is likely to preclude study treatment or comparisons except for nonmelanoma skin cancer\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* See Disease Characteristics\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* Not specified\n\nSurgery:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00002895', 'briefTitle': 'Early Chemotherapy Based on CA 125 Level Alone Compared With Delayed Chemotherapy in Treating Patients With Recurrent Ovarian Epithelial , Fallopian Tube, or Primary Peritoneal Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Randomised Trial in Relapsed Ovarian Cancer: Early Treatment Based on CA 125 Levels Alone Vs. Delayed Treatment Based On Conventional Clinical Indicators', 'orgStudyIdInfo': {'id': 'CDR0000065218'}, 'secondaryIdInfos': [{'id': 'MRC-OV05'}, {'id': 'EORTC-55955'}, {'id': 'ISRCTN87786644'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'chemotherapy', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A-1100', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Kaiser Franz Josef Hospital', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Institut Jules Bordet', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1090', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Academisch Ziekenhuis der Vrije Universiteit Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': 'B-8500', 'city': 'Kortrijk', 'country': 'Belgium', 'facility': "Cazk Groeninghe - Campus Maria's Voorzienigheid", 'geoPoint': {'lat': 50.82803, 'lon': 3.26487}}, {'zip': '14076', 'city': 'Caen', 'country': 'France', 'facility': 'Centre Regional Francois Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '8', 'city': 'Dublin', 'country': 'Ireland', 'facility': "Coombe Women's Hospital", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': '8', 'city': 'Dublin', 'country': 'Ireland', 'facility': "St. James' Hospital", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': '25124', 'city': 'Brescia', 'country': 'Italy', 'facility': 'Spedali Civili di Brescia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academisch Medisch Centrum at University of Amsterdam', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '2300 RC', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': 'NL-6500 HB', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Nijmegen Cancer Center at Radboud University Medical Center', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '3008 AE', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Daniel Den Hoed Cancer Center at Erasmus Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '2545 CH', 'city': 'The Hague', 'country': 'Netherlands', 'facility': 'Leyenburg Ziekenhuis', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'zip': '3508 GA', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'University Medical Center Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '8000 GK', 'city': 'Zwolle', 'country': 'Netherlands', 'facility': 'Isala Klinieken - locatie Sophia', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}, {'zip': '3001-301', 'city': 'Coimbra', 'country': 'Portugal', 'facility': 'Hospitais da Universidade de Coimbra (HUC)', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}, {'zip': '7925', 'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Groote Schuur Hospital', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '08017', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Institut d'Oncologia Corachan", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'HA6 2RN', 'city': 'Northwood', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Mount Vernon Cancer Centre at Mount Vernon Hospital', 'geoPoint': {'lat': 51.61162, 'lon': -0.42454}}], 'overallOfficials': [{'name': 'Gordon J.S. Rustin, MD', 'affiliation': 'Mount Vernon Cancer Centre at Mount Vernon Hospital'}, {'name': 'M. E.L. van der Burg, MD, PhD', 'affiliation': 'University Medical Center Rotterdam at Erasmus Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical Research Council', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}]}}}