Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-03-04 @ 8:22 PM
Study NCT ID:
NCT01938105
Status:
UNKNOWN
Last Update Posted:
2013-09-26
First Post:
2013-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Chemoradiotherapy Combined With Nimotuzumab for 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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-09-24', 'studyFirstSubmitDate': '2013-09-04', 'studyFirstSubmitQcDate': '2013-09-04', 'lastUpdatePostDateStruct': {'date': '2013-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment related toxicities', 'timeFrame': 'at 1 year', 'description': 'Acute and chronic toxicities.'}, {'measure': 'Tumor response after preoperative treatment', 'timeFrame': 'assessed at 4-5 weeks after the completion of preoperative treatment'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'at 1 year'}, {'measure': 'Overall survival', 'timeFrame': 'at 1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cervical cancer', 'Nimotuzumab', 'Intensity-modulated radiation therapy', 'Concurrent chemoradiotherapy'], 'conditions': ['Locally Advanced Cervical Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the feasibility and efficacy of preoperative nimotuzumab injection combined with concurrent chemoradiotherapy for initially inoperable, locally advanced cervical cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically proven squamous cell cervical cancer\n* Stages IB2-IIIB according to FIGO Staging System\n* Age:18-75\n* ECOG\\<2\n* Normal bone marrow function\n* Initial assessed and considered not candidates for operation\n* Signed study-specific consent form\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Patients with other malignancies\n* Patients who received radiotherapy or chemotherapy previously\n* Presence of uncontrolled life-threatening illness\n* Allergy to platinum or monoclonal antibody'}, 'identificationModule': {'nctId': 'NCT01938105', 'briefTitle': 'Preoperative Chemoradiotherapy Combined With Nimotuzumab for Cervical Cancer', 'organization': {'class': 'OTHER', 'fullName': "People's Hospital of Guangxi Zhuang Autonomous Region"}, 'officialTitle': 'Preoperative Concurrent Chemoradiotherapy Combined With Nimotuzumab Injection for Locally Advanced Cervical Cancer: a Phase II Study', 'orgStudyIdInfo': {'id': 'WJPMF-2013-428-2081'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nimotuzumab+chemoradiotherapy', 'interventionNames': ['Other: Nimotuzumab+chemoradiotherapy']}], 'interventions': [{'name': 'Nimotuzumab+chemoradiotherapy', 'type': 'OTHER', 'description': 'Nimotuzumab 200mg per week will be administered concurrent with platinum-based chemotherapy and intensity-modulated radiation therapy. After the preoperative treatment, patients will be assessed for tumor response and operability. For those who are considered to be candidates for operation, radical surgery will be performed.\n\n\\--------------------------------------------------------------------------------', 'armGroupLabels': ['Nimotuzumab+chemoradiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '530021', 'city': 'Nanning', 'state': 'Guangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Heming Lu, MS', 'role': 'CONTACT', 'email': 'gxheminglu@sina.com', 'phone': '+86-771-218-6503'}, {'name': 'Heming Lu, MS', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yun Mo, MS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "People's Hospital of Guangxi Zhuang Autonomous Region", 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}], 'centralContacts': [{'name': 'Heming Lu, MS', 'role': 'CONTACT', 'email': 'gxheminglu@sina.com', 'phone': '+86-771-218-6503'}], 'overallOfficials': [{'name': 'Heming Lu, MS', 'role': 'STUDY_CHAIR', 'affiliation': "People's Hospital of Guangxi Zhuang Autonomous Region"}, {'name': 'Heming Lu, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "People's Hospital of Guangxi Zhuang Autonomous Region"}, {'name': 'Yun Mo, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "People's Hospital of Guangxi Zhuang Autonomous Region"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "People's Hospital of Guangxi Zhuang Autonomous Region", 'class': 'OTHER'}, 'collaborators': [{'name': 'Wu Jieping Medical Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Heming Lu', 'investigatorAffiliation': "People's Hospital of Guangxi Zhuang Autonomous Region"}}}}