Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-04 @ 5:27 AM
Study NCT ID:
NCT02835404
Status:
UNKNOWN
Last Update Posted:
2016-07-18
First Post:
2016-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pelvic External Combined With 252-Cf Neutron Intracavitary Radiotherapy With or Without Platinum in Treating Advanced 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': 'C053989', 'term': 'nedaplatin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2018-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-13', 'studyFirstSubmitDate': '2016-07-06', 'studyFirstSubmitQcDate': '2016-07-13', 'lastUpdatePostDateStruct': {'date': '2016-07-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute toxicity events', 'timeFrame': 'Week 5 of Radiation Therapy (RT)', 'description': 'chemo-related toxicity as measured by CTCAE v. 4.0, radiation-related toxicity as measured by RTOG/EORTC criteria'}, {'measure': 'Long-trem toxicity events', 'timeFrame': 'through study completion, an average of 5 year', 'description': 'chemo-related toxicity as measured by CTCAE v. 4.0, radiation-related toxicity as measured by RTOG/EORTC criteria'}], 'secondaryOutcomes': [{'measure': '2 Years Overall survial Rate', 'timeFrame': '2 years', 'description': 'chemo-related toxicity as measured by CTCAE v. 4.0, radiation-related toxicity'}, {'measure': '3 Years Overall survial Rate', 'timeFrame': '3 years'}, {'measure': '5 Years Overall survial Rate', 'timeFrame': '5 years'}, {'measure': 'Disease-free survival (DFS)', 'timeFrame': 'through study completion, an average of 3 year'}, {'measure': 'Overall survial (OS)', 'timeFrame': 'through study completion, an average of 5 year'}]}, 'conditionsModule': {'conditions': ['Cervical Cancer', 'Complications']}, 'descriptionModule': {'briefSummary': 'The objective of this study was to evaluate the efficacy and complication of the treatment of pelvic external combined with 252-Cf neutron intracavitary radiotherapy with or without platinum in local advanced cervical cancer patients in the short and long term.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. To be aged from 18 (including 18) to 65 (including 65), female patient;\n* 2\\. Expected survival ≥6 months\n* 3\\. Pathologically proven diagnosis of squamous carcinoma or adenocarcinoma of the cervix, according to FIGO(International Federation of Gynecology and Obstetrics) staging, appropriate stage for protocol entry, including IIA2, IIB,IIIA,IIIB;\n* 4\\. No patients with distant metastases;\n* 5\\. Measurable target lesions (satisfying the criteria in RECIST 1.1);\n* 6\\. ECOG PS status of 0-2;\n* 7\\. No prior treatment;\n* 8\\. No\n* 9\\. No surgery\n* 10\\. Major organ function has to meet the following criteria:\n\n 1. Bilirubin \\<1.5 times the upper limit of normal (ULN)\n 2. ALT , AST and APL≤2.5 × ULN\n 3. NEUT≥2.0 × 10\\^9 / L\n 4. PLT ≥ 100 × 10\\^9 / L\n 5. HB≥60g/L\n 6. Serum Cr and urea nitrogen ≤ 1.5 × ULN\n* 11\\. Favorable cardiac functions, no patients with myocardial infarction within half a year, hypertension and coronary disease are well-controlled.\n\nExclusion Criteria:\n\n* 1\\. Serious heart disease, pulmonary disease, hepatic disease, , renal disease and metabolic disease, or with electrolyte disturbance;\n* 2\\. Allergic to platinum;\n* 3\\. Rejecte to join the study in other conditions.'}, 'identificationModule': {'nctId': 'NCT02835404', 'briefTitle': 'Pelvic External Combined With 252-Cf Neutron Intracavitary Radiotherapy With or Without Platinum in Treating Advanced Cervical Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}, 'officialTitle': 'A Randomized, Open Label, Single Centre Clinical Trial of Pelvic External Radiotherapy Combined With 252-Cf Neutron Intracavitary Brachytherapy With or Without Platinum in Treatment of Local Advanced Cervical Cancer', 'orgStudyIdInfo': {'id': '2012012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Concurrent radiochemotherapy Group', 'description': 'Concurrent radiochemotherapy with Nedaplatin Pelvic External Radiotherapy: patients received 20 Gy2.0/f, for 25-27f with 8mv-X rays (SSD) 252-Cf Neutron Intracavitary Brachytherapy: total dose of reference point A was 4400cGy, in four times Transvaginal implant sessions during Pelvic External Radiations; Chemotherapy: Nedaplatin(NDP) 30-40mg/m2 iv., on day1, 4weeks as one cycle', 'interventionNames': ['Drug: Nedaplatin', 'Radiation: Pelvic External Radiotherapy', 'Radiation: 252-Cf Neutron Intracavitary Brachytherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Radiotherapy Group', 'description': 'patients received Radiotherapy only Pelvic External Radiotherapy: patients received 20 Gy2.0/f, for 25-27f (SSD)with 8mv-X Linear Accelerator SSD 252-Cf Neutron Intracavitary Brachytherapy: total dose of reference point A was 4400cGy, in four times Transvaginal implant sessions during Pelvic External Radiations.', 'interventionNames': ['Radiation: Pelvic External Radiotherapy', 'Radiation: 252-Cf Neutron Intracavitary Brachytherapy']}], 'interventions': [{'name': 'Nedaplatin', 'type': 'DRUG', 'otherNames': ['NDP'], 'description': 'Chemotherapy: Nedaplatin(NDP) 30-40mg/m2 iv., on day1, 4weeks as one cycle', 'armGroupLabels': ['Concurrent radiochemotherapy Group']}, {'name': 'Pelvic External Radiotherapy', 'type': 'RADIATION', 'description': 'patients received 20 Gy2.0/f, for 25-27f (SSD)with 8mv-X rays (SSD)', 'armGroupLabels': ['Concurrent radiochemotherapy Group', 'Radiotherapy Group']}, {'name': '252-Cf Neutron Intracavitary Brachytherapy', 'type': 'RADIATION', 'description': 'total dose of reference point A was 4400cGy, in four times Transvaginal implant sessions during Pelvic External Radiations', 'armGroupLabels': ['Concurrent radiochemotherapy Group', 'Radiotherapy Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chongqing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xin Lei, M.D', 'role': 'CONTACT'}], 'facility': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Xin Lei, M.D', 'role': 'CONTACT', 'email': 'dpxinlei@126.com', 'phone': '+86 023-68757176'}], 'overallOfficials': [{'name': 'Xin Lei, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D, Prof.', 'investigatorFullName': 'Xin Lei, M.D.Prof', 'investigatorAffiliation': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}}}}