Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2026-01-11 @ 9:46 PM
Study NCT ID:
NCT00592059
Status:
UNKNOWN
Last Update Posted:
2008-01-11
First Post:
2007-12-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Systemic Consolidation Therapy After Chemoradiation Therapy Following Operation for High Risk Early Stage 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': 77}}, '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': '2007-12-28', '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 radical hysterectomy and adjuvant chemoradiation for high risk early stage cervical cancer.', 'detailedDescription': 'Systemic consolidation therapy with paclitaxel plus carboplatin (3 cycles per 3 weeks) following radical hysterectomy and adjuvant chemoradiation (3 cycles per 3 weeks) for high risk early stage 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': '75 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who underwent radical hysterectomy for cervical cancer stage IB-IIA\n* Patients who had at least one of the following risk factors in pathologic results; lymph node metastasis, positive residual resection margin, parametrial invasion\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 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': 'NCT00592059', 'briefTitle': 'Systemic Consolidation Therapy After Chemoradiation Therapy Following Operation for High Risk Early Stage Cervical Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Phase II Study of Systemic Consolidation Therapy With Paclitaxel Plus Carboplatin Following Radical Hysterectomy and Adjuvant Chemoradiation for High Risk Early Stage Cervical Cancer', 'orgStudyIdInfo': {'id': 'Sece-1'}}, '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}}], 'centralContacts': [{'name': 'Seung Su Han, MD', 'role': 'CONTACT', 'email': 'hsuu3415@snu.ac.kr', 'phone': '082-02-2072-2821', 'phoneExt': '2821'}], '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'}}}}