Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2026-02-23 @ 8:08 PM
Study NCT ID:
NCT02923258
Status:
COMPLETED
Last Update Posted:
2024-06-20
First Post:
2016-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative CCRT With Docetaxel vs Cisplatin in High Risk Oral Cavity Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'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': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 224}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-17', 'studyFirstSubmitDate': '2016-10-03', 'studyFirstSubmitQcDate': '2016-10-03', 'lastUpdatePostDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free survival (DFS)', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': '2 years', 'description': 'the time in months between the date of random assignment and the date of death from any cause'}, {'measure': 'Locoregional failure-free survival (LRFS)', 'timeFrame': '2 years', 'description': 'the time in months between random assignment and the date of first locoregional recurrence or death from any cause, whichever occurred first'}, {'measure': 'distant metastasis free survival (DMFS)', 'timeFrame': '2 years', 'description': 'the time from random assignment to the first distant metastasis or death from any cause'}, {'measure': 'Adverse Events (AE)', 'timeFrame': '3 months', 'description': 'AEs were summarized and recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oral cavity squamous cell carcinoma', 'concurrent chemotherapy', 'High-Risk'], 'conditions': ['Oral Cavity Squamous Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '39075531', 'type': 'DERIVED', 'citation': 'Jiang W, Chen L, Li R, Li J, Dou S, Ye L, He Y, Tian Z, Yao Y, Zhu G. Postoperative radiotherapy with docetaxel versus cisplatin for high-risk oral squamous cell carcinoma: a randomized phase II trial with exploratory analysis of ITGB1 as a potential predictive biomarker. BMC Med. 2024 Jul 29;22(1):314. doi: 10.1186/s12916-024-03541-6.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized,controled, phase II, open label study of postoperative concurrent chemoradiotherapy with Docetaxel versus Cisplatin for high-risk squamous cell carcinoma of the oral cavity cancer.The primary purpose of this study is to evaluate the efficacy of concurrent chemoradiotherapy with docetaxel in OCC patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1.Histologically confirmed squamous cell carcinoma of the oral cavity 2. Gross total resection, with pathology demonstrating one or more of the following risk factors:\n\n 1. Histologic extracapsular nodal extension\n 2. Histologic involvement of ≥ 2 regional lymph nodes\n 3. Invasive cancer is seen on microscopic evaluation of the resection margin, with no evidence of gross tumor residual 3. No evidence of distant metastases 4. No synchronous or concurrent head and neck primary tumors 5. ECOG 0-1 6. Adequate organ function including the following:\n\n <!-- -->\n\n 1. Absolute neutrophil count (ANC) \\>= 1.5 \\* 10\\^9/l\n 2. Platelets count \\>= 100 \\* 10\\^9/l\n 3. Hemoglobin \\>= 10 g/dl\n 4. AST and ALT \\<= 2.5 times institutional upper limit of normal (ULN)\n 5. Total bilirubin \\<= 1.5 times institutional ULN\n 6. Creatinine clearance \\>= 50 ml/min\n 7. Serum creatine \\<= 1 times ULN 7.Signed written informed consent\n\nExclusion Criteria:\n\n* 1\\. Evidence of distant metastasis 2. Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region 3. Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma 4. Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures 5.Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia'}, 'identificationModule': {'nctId': 'NCT02923258', 'briefTitle': 'Postoperative CCRT With Docetaxel vs Cisplatin in High Risk Oral Cavity Cancer', 'organization': {'class': 'OTHER', 'fullName': "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University"}, 'officialTitle': 'Postoperative Radiation and Concurrent Chemotherapy With Weekly Docetaxel Versus Cisplatin in Patients With High-risk Oral Cavity Cancer: a Randomized Phase II Clinical Trial', 'orgStudyIdInfo': {'id': '2016HNRT004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Concurrent Chemoradiotherapy With Docetaxel and IMRT', 'interventionNames': ['Drug: Docetaxel', 'Radiation: IMRT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Concurrent Chemoradiotherapy With Cisplatinum and IMRT', 'interventionNames': ['Drug: Cisplatin', 'Radiation: IMRT']}], 'interventions': [{'name': 'Docetaxel', 'type': 'DRUG', 'description': '20mg/m2/w', 'armGroupLabels': ['Experimental']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': '100mg/m2/q3w', 'armGroupLabels': ['Control']}, {'name': 'IMRT', 'type': 'RADIATION', 'description': 'a total dose of 60Gy in 30fractions over 6 weeks', 'armGroupLabels': ['Control', 'Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200011', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Shanghai ninth people's hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Guopei Zhu', 'role': 'STUDY_CHAIR', 'affiliation': "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Guopei Zhu', 'investigatorAffiliation': "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University"}}}}