Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-28 @ 4:22 AM
Study NCT ID:
NCT00046969
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2002-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epoetin Beta in Treating Anemia in Patients With Cervical Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C103998', 'term': 'epoetin beta'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D001918', 'term': 'Brachytherapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-29', 'studyFirstSubmitDate': '2002-10-03', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-05-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of treatment failures within 6 months after beginning radiochemotherapy (RCT) (stage I)'}, {'measure': 'Overall survival after RCT (stage II)'}], 'secondaryOutcomes': [{'measure': 'Progression/relapse-free survival'}, {'measure': 'Overall response rate to RCT'}, {'measure': 'Overall survival after RCT (stage I)'}, {'measure': 'Frequency and localization of relapses and/or metastases'}, {'measure': 'Change in hemoglobin from baseline during therapy'}, {'measure': 'Quality of life as assessed by the Functional Assessment of Cancer Therapy-Anemia'}, {'measure': 'Type, frequency, and degree of adverse events'}, {'measure': 'Safety'}, {'measure': 'Vital signs'}, {'measure': 'Number of treatment failures within 6 months after beginning RCT (stage II)'}]}, 'conditionsModule': {'keywords': ['anemia', 'stage IIB cervical cancer', 'stage III cervical cancer', 'stage IVA cervical cancer', 'cervical adenosquamous cell carcinoma', 'cervical squamous cell carcinoma', 'cervical adenocarcinoma'], 'conditions': ['Anemia', 'Cervical Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Epoetin beta may stimulate red blood cell production to prevent or control anemia in patients treated with chemotherapy and radiation therapy.\n\nPURPOSE: Randomized phase IV trial to determine the effectiveness of epoetin beta in treating anemia in patients who are receiving cisplatin and radiation therapy for stage IIB, stage III, or stage IVA cervical cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the effectiveness of epoetin beta vs standard care for anemia management, in terms of increased hemoglobin levels and the correlation with reduced relapse/treatment failure rate, in patients with stage IIB, III, or IVA cervical cancer treated with cisplatin and radiotherapy.\n* Compare the safety of these regimens in these patients.\n* Compare the relapse-free and overall survival of patients treated with these regimens.\n* Compare the frequency and localization of relapses and metastases in patients treated with these regimens.\n* Compare the quality of life of patients treated with these regimens.\n* Compare the type, frequency, and degree of adverse events in patients treated with these regimens.\n* Compare the overall response rate in patients treated with these regimens.\n\nOUTLINE: This is a randomized, open-label, parallel-group, multicenter study. Patients are stratified according to country, disease stage, and brachytherapy technique. Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients undergo radiotherapy 5 days a week for 6 weeks. Patients also undergo high-dose rate, low-dose rate, or boost brachytherapy. Patients receive cisplatin IV beginning on day 1 of radiotherapy and continuing weekly for 6 weeks. Patients also receive epoetin beta subcutaneously 3 times a week beginning 2 weeks before radiotherapy and continuing for 8 weeks.\n* Arm II: Patients undergo radiotherapy and brachytherapy and receive cisplatin as in arm I.\n\nQuality of life is assessed at baseline, after the last treatment, and at 3 months.\n\nPatients are followed every 3 months for 2 years and then every 6 months thereafter.\n\nPROJECTED ACCRUAL: A total of 80-450 patients will be accrued for this study within 4-22.5 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed stage IIB, III, or IVA cervical cancer\n\n * No chorion carcinoma or neuroendocrine small cell carcinoma\n * Previously untreated disease\n* Must be scheduled to undergo radiotherapy and receive cisplatin as primary therapy\n* Hemoglobin 8.0-13.0 g/dL\n* No relevant acute bleeding within the past 3 months, including anemia caused by gross bleeding from tumor\n* No distant metastasis\n* No positive para-aortic lymph nodes\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* Over 18\n\nPerformance status\n\n* WHO 0-2\n\nLife expectancy\n\n* At least 3 months\n\nHematopoietic\n\n* See Disease Characteristics\n* WBC greater than 3,000/mm3\n* Platelet count greater than 100,000/mm3\n* No hemolytic anemia\n* No transferrin saturation less than 20% that cannot be treated with IV iron\n* No hemoglobinopathies (i.e., sickle cell disease or thalassemia of all types)\n\nHepatic\n\n* Bilirubin no greater than 1.5 times upper limit of normal (ULN)\n* Transaminases no greater than 2.5 times ULN\n* Alkaline phosphatase no greater than 2.5 times ULN\n\nRenal\n\n* Creatinine clearance greater than 60 mL/min\n\nCardiovascular\n\n* No chronic heart failure\n* No New York Heart Association class II-IV heart disease\n* No uncontrolled arterial hypertension (systolic blood pressure at least 170 mmHg, diastolic blood pressure at least 100 mmHg)\n* No prior deep vein thrombosis\n* No thrombocytosis\n\nOther\n\n* No vitamin B12 deficiency\n* No folic acid deficiency\n* No newly diagnosed (unstable) epilepsy\n* No acute infection\n* No other malignancy within the past 5 years except basal cell carcinoma in situ\n* No known peripheral neuropathy or moto-sensory neurotoxicity grade 2 or greater\n* No impaired hearing grade 2 or greater\n* No hypersensitivity to benzyl alcohol, benzoic acid, benzalkonium chloride, or any excipients of cisplatin preparations\n* Not pregnant or nursing\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* At least 3 months since prior epoetins or related compounds\n\nChemotherapy\n\n* See Disease Characteristics\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* See Disease Characteristics\n* No prior radiotherapy for cervical cancer\n\nSurgery\n\n* Not specified\n\nOther\n\n* At least 30 days since prior investigational drugs\n* No prior systemic antineoplastic therapy for cervical cancer\n* No other concurrent investigational drugs'}, 'identificationModule': {'nctId': 'NCT00046969', 'briefTitle': 'Epoetin Beta in Treating Anemia in Patients With Cervical Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Management Of Anemia Under RadioChemotherapy (MARCH): An Open, Randomized Multicenter Study Of The Effect Of NeoRecormon On Treatment Outcome In Patients With Advanced Cervical Cancer Stage IIB -IVA Treated With Primary Simultaneous Radiochemotherapy (Radiotherapy Plus Cisplatin)', 'orgStudyIdInfo': {'id': 'AGOSG-OVAR-MO16375-MARCH'}, 'secondaryIdInfos': [{'id': 'CDR0000257189', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'EU-20217'}, {'id': 'ROCHE-MO16375'}, {'id': 'ROCHE-RO2053859'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'epoetin beta', 'type': 'BIOLOGICAL'}, {'name': 'cisplatin', 'type': 'DRUG'}, {'name': 'brachytherapy', 'type': 'RADIATION'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-06097', 'city': 'Halle', 'country': 'Germany', 'facility': 'Martin Luther Universitaet', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}], 'overallOfficials': [{'name': 'Heinz Koelbl, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Martin-Luther-Universität Halle-Wittenberg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AGO Study Group', 'class': 'OTHER'}}}}