Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-25 @ 5:32 PM
Study NCT ID:
NCT00017004
Status:
COMPLETED
Last Update Posted:
2017-08-09
First Post:
2001-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Radiation Therapy and Cisplatin With or Without Epoetin Alfa in Treating Patients With Cervical Cancer and Anemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada', 'Norway', 'United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'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': 'D002945', 'term': 'Cisplatin'}, {'id': 'D001918', 'term': 'Brachytherapy'}, {'id': 'D000068817', 'term': 'Epoetin Alfa'}, {'id': 'D004921', 'term': 'Erythropoietin'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'lastUpdateSubmitDate': '2017-08-08', 'studyFirstSubmitDate': '2001-06-06', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival with progression defined as a 50% or greater increase in the cross-product of the existing primary tumor relative to the smallest cross-product from all previous exams', 'timeFrame': 'Up to 5 years'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Up to 5 years'}, {'measure': 'Local control, coded as successful if any relapse or disease progression is is contained within the pelvic field', 'timeFrame': 'Up to 5 years'}]}, 'conditionsModule': {'conditions': ['Anemia', 'Cervical Adenocarcinoma', 'Cervical Adenosquamous Carcinoma', 'Cervical Squamous Cell Carcinoma', 'Drug Toxicity', 'Radiation Toxicity', 'Stage IIB Cervical Cancer', 'Stage III Cervical Cancer', 'Stage IVA Cervical Cancer']}, 'descriptionModule': {'briefSummary': 'Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Epoetin alfa may stimulate red blood cell production to treat anemia in patients who have received chemotherapy and/or radiation therapy for cervical cancer. Randomized phase III trial to study the effectiveness of epoetin alfa in treating anemia in patients who have cervical cancer.', 'detailedDescription': 'OBJECTIVES:\n\nAssess the efficacy of raising and maintaining hemoglobin (Hgb) levels above 12.0 g/dL with epoetin alfa vs maintaining Hgb levels above 10.0 g/dL without epoetin alfa on progression-free survival, overall survival, and local control in anemic patients with cervical cancer receiving concurrent radiotherapy and cisplatin. Compare the quality of life of patients treated with these regimens.\n\nOUTLINE:\n\nThis is a randomized study. Patients are stratified according to stage (IIB vs IIIB vs IVA), method of brachytherapy (low-dose vs high-dose), and surgical staging of para-aortic nodes (yes vs no). Patients are randomized to 1 of 2 treatment arms.\n\nArm I: Patients undergo radiotherapy comprising pelvic external beam radiotherapy daily five days a week for 5 weeks, followed by either 1 or 2 implants of low-dose rate intracavitary brachytherapy or 5 fractions of high-dose rate intracavitary brachytherapy, followed by 3-5 days of parametrial boost radiotherapy. Patients receive cisplatin IV concurrently with pelvic external beam radiotherapy on days 1, 8, 15, 22, 29, and once during the week of parametrial boost radiotherapy.\n\nArm II: Patients undergo radiotherapy and chemotherapy as in arm I. Additionally, patients receive epoetin alfa subcutaneously once weekly concurrently with radiotherapy and chemotherapy. Quality of life is assessed at baseline, during weeks 3 and 6, within 1 week of last brachytherapy, and every 3 months for 2 years. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 460 patients will be accrued for this study within 3.5 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix\n\n * Stage IIB, IIIB, or IVA\n * Primary, previously untreated disease\n* Hemoglobin less than 14 g/dL at presentation\n* Negative, non-suspicious para-aortic nodes determined by lymphangiogram, CT scan, MRI, or lymphadenectomy\n* Eligible for treatment with radical intent involving concurrent cisplatin and pelvic radiotherapy\n* No involvement of the lower third of vagina\n* No carcinoma of the cervical stump\n* Performance status - GOG 0-3\n* See Disease Characteristics\n* Absolute neutrophil count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* Bilirubin no greater than 1.5 times normal\n* SGOT no greater than 3 times normal\n* Alkaline phosphatase no greater than 3 times normal\n* Creatinine no greater than 2.0 mg/dL\n* No uncontrolled hypertension\n* No history of thrombotic vascular events (e.g., deep vein thrombosis or myocardial infarction)\n* No active hemolysis\n* No history of pulmonary embolism\n* No septicemia or severe infection\n* No circumstances that would preclude study participation\n* No other invasive malignancy within the past 5 years except nonmelanoma skin cancer\n* No history of hypersensitivity to epoetin alfa or human albumin\n* No diagnosis of vitamin B\\_12 or folic acid deficiency\n* No recent (within the past 3 months) or uncontrolled seizure disorder\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* See Disease Characteristics\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00017004', 'briefTitle': 'Radiation Therapy and Cisplatin With or Without Epoetin Alfa in Treating Patients With Cervical Cancer and Anemia', 'organization': {'class': 'NETWORK', 'fullName': 'GOG Foundation'}, 'officialTitle': 'Phase III Trial to Evaluate the Efficacy of Maintaining Hemoglobin Levels Above 120 g/l With Erythropoietin Versus Above 100 g/l Without Erythropoietin in Anemic Patients Receiving Concurrent Radiation and Cisplatin for Cervical Cancer', 'orgStudyIdInfo': {'id': 'GOG-0191'}, 'secondaryIdInfos': [{'id': 'NCI-2012-02384', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CAN-NCIC-CX4'}, {'id': 'CDR0000068641'}, {'id': 'GOG-0191', 'type': 'OTHER', 'domain': 'Gynecologic Oncology Group'}, {'id': 'GOG-0191', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA027469', 'link': 'https://reporter.nih.gov/quickSearch/U10CA027469', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I', 'description': 'Patients undergo radiotherapy comprising pelvic external beam radiotherapy daily five days a week for 5 weeks, followed by either 1 or 2 implants of low-dose rate intracavitary brachytherapy or 5 fractions of high-dose rate intracavitary brachytherapy, followed by 3-5 days of parametrial boost radiotherapy. Patients receive cisplatin IV concurrently with pelvic external beam radiotherapy on days 1, 8, 15, 22, 29, and once during the week of parametrial boost radiotherapy.', 'interventionNames': ['Radiation: External Beam Radiation Therapy', 'Drug: Cisplatin', 'Radiation: Internal Radiation Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II', 'description': 'Patients undergo radiotherapy and chemotherapy as in arm I. Additionally, patients receive epoetin alfa subcutaneously once weekly concurrently with radiotherapy and chemotherapy.', 'interventionNames': ['Radiation: External Beam Radiation Therapy', 'Drug: Cisplatin', 'Radiation: Internal Radiation Therapy', 'Biological: Epoetin Alfa']}], 'interventions': [{'name': 'External Beam Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['Definitive Radiation Therapy', 'EBRT', 'External Beam RT'], 'description': 'Undergo radiation', 'armGroupLabels': ['Arm I', 'Arm II']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': 'Given IV', 'armGroupLabels': ['Arm I', 'Arm II']}, {'name': 'Internal Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['Brachytherapy', 'Internal Radiation', 'Internal Radiation Brachytherapy', 'Radiation Brachytherapy'], 'description': 'Undergo radiation', 'armGroupLabels': ['Arm I', 'Arm II']}, {'name': 'Epoetin Alfa', 'type': 'BIOLOGICAL', 'otherNames': ['EPO', 'Epogen', 'Eprex', 'erythropoietin', 'r-HuEPO'], 'description': 'Given SC', 'armGroupLabels': ['Arm II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Gynecologic Oncology Group of Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'Gillian Thomas', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gynecologic Oncology Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynecologic Oncology Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Canadian Cancer Trials Group', 'class': 'NETWORK'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}