Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-01-02 @ 8:53 AM
Study NCT ID:
NCT05860868
Status:
RECRUITING
Last Update Posted:
2023-05-16
First Post:
2023-05-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Two Cycles VS Three Cycles Induction Chemotherapy in T1-4N2-3 Locally Advanced Nasopharyngeal Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 474}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2030-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-06', 'studyFirstSubmitDate': '2023-05-06', 'studyFirstSubmitQcDate': '2023-05-06', 'lastUpdatePostDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FFS, Failure Free Survival', 'timeFrame': '3 years', 'description': 'Defined as the time from randomization to tumor recurrence, distant metastasis, or death due to any reason, whichever occurs first. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and progression free. Patients not having an event will be censored at the date last seen alive.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Locally Advanced Nasopharyngeal Carcinoma']}, 'descriptionModule': {'briefSummary': 'This trial is a multi-center phase III clinical trial. The purpose of this trial is to explore whether 2 cycles induction chemotherapy combined with concurrent chemoradiotherapy is not inferior to 3 cycles induction chemotherapy combined with concurrent chemoradiotherapy in patients with locally advanced nasopharyngeal carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-65 years old;\n2. Pathologically confirmed non-keratinizing nasopharyngeal carcinoma;\n3. Stage T3-4N0-1 (according to the UICC/AJCC 8th);\n4. No distant metastasis;\n5. Have not received anti-cancer treatment in the past;\n6. ECOG (Eastern Cooperative Oncology Group of the United States): 0-1;\n7. Adequate hematologic, hepatic and renal function.\n\nExclusion Criteria:\n\n1. The purpose of treatment is palliative;\n2. Diagnosed with other malignant tumors at the same time;\n3. Malignant tumor history;\n4. Pregnancy or breastfeeding, or expect to become pregnant during the clinical trial period;\n5. Combined serious illness.'}, 'identificationModule': {'nctId': 'NCT05860868', 'briefTitle': 'Two Cycles VS Three Cycles Induction Chemotherapy in T1-4N2-3 Locally Advanced Nasopharyngeal Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital, Sun Yat-Sen University'}, 'officialTitle': 'Two Cycles VS Three Cycles Induction Chemotherapy Plus Concurrent Chemoradiotherapy in T1-4N2-3 Locally Advanced Nasopharyngeal Carcinoma', 'orgStudyIdInfo': {'id': 'Two VS Three'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2 cycles', 'description': '2 cycles induction + concurrent chemoradiotherapy', 'interventionNames': ['Drug: 2 cycles induction chemotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3 cycles', 'description': '3 cycles induction + concurrent chemoradiotherapy', 'interventionNames': ['Drug: 3 cycles induction chemotherapy']}], 'interventions': [{'name': '2 cycles induction chemotherapy', 'type': 'DRUG', 'description': 'Drug: 2 cycles Induction Chemotherapy Induction regimens: TP (docetaxel 75 mg/m²; cisplatin 75 mg/m²) Q3w, TPF (docetaxel 60 mg/m²; cisplatin 60 mg/m²; 5-fluorouracil 600-750 mg/m² per day, continuous intravenous infusion d1-5) Q3w, or GP (gemcitabine: 1000 mg/m2 d1, d8; cisplatin 80 mg/m2) Q3w.\n\nDrug: Concurrent Chemotherapy Cisplatin 100 mg/m², Q3w.\n\nRadiation: Definitive Radiotherapy For all patients, the prescribed dose is 66-70 Gy (once a day, 5 times a week).', 'armGroupLabels': ['2 cycles']}, {'name': '3 cycles induction chemotherapy', 'type': 'DRUG', 'description': 'Drug: 3 cycles Induction Chemotherapy Induction regimens: TP (docetaxel 75 mg/m²; cisplatin 75 mg/m²) Q3w, TPF (docetaxel 60 mg/m²; cisplatin 60 mg/m²; 5-fluorouracil 600-750 mg/m² per day, continuous intravenous infusion d1-5) Q3w, or GP (gemcitabine: 1000 mg/m2 d1, d8; cisplatin 80 mg/m2) Q3w.\n\nDrug: Concurrent Chemotherapy Cisplatin 100 mg/m², Q3w.\n\nRadiation: Definitive Radiotherapy For all patients, the prescribed dose is 66-70 Gy (once a day, 5 times a week).', 'armGroupLabels': ['3 cycles']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Other (Non U.s.)', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Cheng-Tao Wang', 'role': 'CONTACT', 'email': 'wangcht5@mail.sysu.edu.cn', 'phone': '+862087755766'}], 'facility': 'First Affiliated Hospital, Sun Yat-Sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Cheng-Tao Wang', 'role': 'CONTACT', 'email': 'wangcht5@mail.sysu.edu.cn', 'phone': '+862087755766'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Chen Yong', 'investigatorAffiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}}}}