Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-01-06 @ 12:53 PM
Study NCT ID:
NCT00591656
Status:
UNKNOWN
Last Update Posted:
2008-01-11
First Post:
2007-12-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Systemic Consolidation Therapy After Primary Chemoradiation Therapy for Locally 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 69}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2012-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-12-31', 'studyFirstSubmitDate': '2007-12-31', 'studyFirstSubmitQcDate': '2007-12-31', 'lastUpdatePostDateStruct': {'date': '2008-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cervical Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the therapeutic efficacy and complications of systemic consolidation therapy with paclitaxel plus carboplatin following primary chemoradiation for locally advanced cervical cancer.', 'detailedDescription': 'Systemic consolidation therapy with paclitaxel plus carboplatin (3 cycles per 3 weeks) following primary chemoradiation (3 cycles per 3 weeks) for locally advanced cervical cancer will elevate the therapeutic efficacy by removing the microscopic metastatic lesions which could not be identified by naked eye and diagnostic imaging tests.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who underwent three cycles of concurrent chemoradiation therapy with paclitaxel and carboplatin for non-small cell type cervical cancer stage IB2, bulky size (\\>4cm) IIA,IIB-IVA\n* above 20 years\n* GOG performance status 0-2\n* Informed consent\n* Platelet\\>100K, Hb\\> 10.0 g/dl, ANC\\>1500/mm3, Cr \\<1.25\\*upper normal limit, bilirubin\\<1.5mg/dl, AST \\& ALT\\<\\*3 upper normal limit\n* Expected life \\> 6 months\n\nExclusion Criteria:\n\n* Peripheral neurotoxicity \\> NCI CTCAE grade 2\n* Sever infection\n* Previous history with chemotherapy or radiation therapy\n* Pleural effusion, pericardial effusion, and ascites which could cause dyspnea \\> NCI grade 2\n* Paraaortic lymph node metastasis\n* Allergy with platinum\n* Previous history of atrial or ventricular arrhythmia or congestive heart failure\n* Uncontrolled infection, diabetes mellitus, hypertension, ischemic heart disease, myocardiac infarct within 6 months\n* Severe disease such as acute or chronic renal failure and acute cerebral infarct, cerebral hemorrhage, recurrent hepatitis, liver cirrhosis, unknown fever above 39 degrees centigrade'}, 'identificationModule': {'nctId': 'NCT00591656', 'briefTitle': 'Systemic Consolidation Therapy After Primary Chemoradiation Therapy for Locally Advanced Cervical Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Phase II Study of Systemic Consolidation Therapy With Paclitaxel Plus Carboplatin Following Primary Chemoradiation for Locally Advanced Cervical Cancer', 'orgStudyIdInfo': {'id': 'Sece-2'}, 'secondaryIdInfos': [{'id': 'SECE-2'}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seung Su Han, MD', 'role': 'CONTACT', 'email': 'hsuu3415@snu.ac.kr', 'phone': '082-02-2072-2821', 'phoneExt': '2821'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jae Weon Kim, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seoul National University Hospital'}, {'name': 'Seung Su Han, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jae Weon Kim', 'oldOrganization': 'Seoul National University Hospital'}}}}