Ignite Creation Date:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-26 @ 4:03 PM
Study NCT ID:
NCT05367206
Status:
RECRUITING
Last Update Posted:
2022-05-10
First Post:
2022-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neoadjuvant Chemotherapy Followed by Chemoradiation Versus Chemoradiation for Stage IIIC Cervical Cancer Patients: A Randomized Phase III Trial
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': 'D000068196', 'term': 'Albumin-Bound Paclitaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D000418', 'term': 'Albumins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-09', 'studyFirstSubmitDate': '2022-05-01', 'studyFirstSubmitQcDate': '2022-05-09', 'lastUpdatePostDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3-year progression-free survival ratio', 'timeFrame': 'up to 3 years', 'description': 'the time from study randomization to 3 years, the ratio for patients without disease progression nor death.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cervical cancer', 'neoadjuvant chemotherapy', 'bulky neoplasm'], 'conditions': ['Cervical Cancer', 'Neoadjuvant Chemotherapy', 'Bulky Neoplasm']}, 'descriptionModule': {'briefSummary': 'Evaluate the efficacy and safety of neoadjuvant chemotherapy (NAC) with albumin-bound paclitaxel and carboplatin followed by chemoradiation therapy (CRT) for stage IIIC cervical cancer patients with carcinoma \\>4 cm in greatest dimension and/or lymph node \\>2cm in short axis.', 'detailedDescription': 'in this phase III tiral , stage IIIC cervical cancer patients with carcinoma \\>4 cm in greatest dimension and/or lymph node \\>2cm in short axis will be randomly assigned to two circles of NAC with albumin-bound paclitaxel and carboplatin followed by standard CRT with weekly cisplatin plus pelvic radiotherapy or to standard CRT alone.\n\nThe primary end point was 3-year progression-free survival (PFS). Secondary end points were response rate, 3-year locoregional control, 3-year overall survival (OS), safety, and quality of life.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. pathologically comfirmed : squamous cell, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix；\n2. FIGO (2018 International Federation of Gynecology and Obstetrics) stage IIIC with carcinoma \\>4 cm in greatest dimension and/or lymph node \\>2 cm in short axis at initial diagnosis.\n3. age 18 to 70 years；\n4. Eastern Cooperative Oncology Group performance status 0 to 2；\n5. adequate organ function.\n\nExclusion Criteria:\n\n1\\. not at initial diagnosis; 2. with other kind of tumor.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05367206', 'acronym': 'N6C', 'briefTitle': 'Neoadjuvant Chemotherapy Followed by Chemoradiation Versus Chemoradiation for Stage IIIC Cervical Cancer Patients: A Randomized Phase III Trial', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Department of Radiation, Sun Yat-sen University', 'orgStudyIdInfo': {'id': 'SunYat-sen University'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NAC plus RCT', 'description': 'two circles of NAC with albumin-bound paclitaxel and carboplatin followed by standard chemoradiation with weekly cisplatin plus pelvic radiation', 'interventionNames': ['Drug: Albumin-Bound Paclitaxel', 'Drug: Carboplatin']}, {'type': 'NO_INTERVENTION', 'label': 'RCT', 'description': 'standard chemoradiation with weekly cispatin plus pelvic radiation'}], 'interventions': [{'name': 'Albumin-Bound Paclitaxel', 'type': 'DRUG', 'description': '260mg/m2 q3w \\*2 circles', 'armGroupLabels': ['NAC plus RCT']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'AUC 5-6 q3w \\* 2 circles', 'armGroupLabels': ['NAC plus RCT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdone', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Junyun Li, M.D.', 'role': 'CONTACT', 'email': 'LIJUNY@sysucc.org.cn', 'phone': '020-87343817', 'phoneExt': '86'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Junyun Li, M.D.', 'role': 'CONTACT', 'email': 'LIJUNY@sysucc.org.cn', 'phone': '020-87343817', 'phoneExt': '86'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Li Junyun', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}