Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-01-02 @ 6:49 AM
Study NCT ID:
NCT02247232
Status:
COMPLETED
Last Update Posted:
2022-03-04
First Post:
2014-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Study of Z-100 Plus Radiation Therapy to Treat Cervical Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'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': 'C031208', 'term': 'specific substance maruyama'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 793}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-03', 'studyFirstSubmitDate': '2014-09-19', 'studyFirstSubmitQcDate': '2014-09-19', 'lastUpdatePostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '5Years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cervical Cancer']}, 'descriptionModule': {'briefSummary': 'This study is a phase III, multicenter, double-blind, placebo-controlled, parallel group comparative study to evaluate the efficacy and safety of Z-100 with primary uterine cervical cancer on radiotherapy. The study will use a central randomization with a dynamic allocation using biased coin minimization.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. FIGO stage (2008): IIIB, cervical cancer;\n2. Pathologically confirmed squamous cell carcinoma of the cervix;\n3. Patients with treatment-naive cervical cancer;\n4. Patients without enlargement (≥15 mm in the short axis) in the lower abdominal para-aortic lymph node confirmed by CT scanning (Patients need not repeat CT scan at screening if CT data \\[film or electronic image\\] within 30 days before informed consent are available and can be provided for central imaging assessment);\n5. Patients ≥21, ≤79 years of age at informed consent;\n6. Patients for whom it is considered possible to carry out intracavitary radiation in radiotherapy;\n7. Eastern Cooperative Oncology Group Performance Status: 0-2;\n8. Patients with the following organ functions; (1) WBC ≥3,000/mm3; (2) Platelet count ≥100,000/mm3; (3) Hemoglobin ≥9.5 g/dL (correction by blood transfusion is allowed); (4) Total bilirubin ≤ three (3) times the upper limit of reference value at the clinical testing laboratory; (5) AST, ALT ≤ three (3) times the upper limit of reference value at the clinical testing laboratory; (6) Renal function:\n\n 1. If combination therapy with cisplatin is planned, creatinine clearance: ≥50 mL/min;\n 2. If combination therapy with cisplatin is not planned, creatinine ≤ twice (2) the upper limit of reference value at the clinical testing laboratory;\n9. Patients who are willing to give informed consents. "'}, 'identificationModule': {'nctId': 'NCT02247232', 'briefTitle': 'Randomized Study of Z-100 Plus Radiation Therapy to Treat Cervical Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zeria Pharmaceutical'}, 'officialTitle': 'Randomized, Double-blind, Placebo-controlled Trial of Z-100 Plus Radiation Therapy in Patients With Locally Advanced Cervical Cancer - A Phase III Trial', 'orgStudyIdInfo': {'id': 'Z100-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Z-100', 'interventionNames': ['Drug: Z-100']}], 'interventions': [{'name': 'Z-100', 'type': 'DRUG', 'armGroupLabels': ['Z-100']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'Zeria Invetigative Sites', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'Zeria Investigative Sites', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'city': 'Singapore', 'country': 'Singapore', 'facility': 'Zeria Investigative Sites', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Zeria Investigative Sites', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Zeria Investigative Sites', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Zeria Investigative Sites', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Hanoi', 'country': 'Vietnam', 'facility': 'Zeria Investrigative Sites', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}], 'overallOfficials': [{'name': 'Keiichi Fujiwara, Prof,MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saitama Medical University International Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zeria Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}