protocolSection identificationModule nctId: NCT06301165, orgStudyIdInfo id: 2023-FXY-129, briefTitle: TPC Versus GP Induction Chemotherapy for Nasopharyngeal Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-19, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: The NCCN guidelines recommend induction chemotherapy followed by concurrent chemoradiotherapy as the standard treatment for locoregionally advanced nasopharyngeal carcinoma (NPC). However, meta-analyses have shown significant survival differences between different induction chemotherapy regimens. How to choose an induction chemotherapy regimen and treatment course that ensures definitive therapeutic effects and low incidence of toxic side effects remains a hot spot in clinical research. Polymeric micellar paclitaxel are an innovative form of paclitaxel drugs, with high penetration and long retention effects, which can enter the vascularly disordered tumor microenvironment through passive targeting and form higher concentrations in tumor tissue. It remains to be investigated whether the TPC (paclitaxel, cisplatin and capecitabine) regimen based on polymeric micellar paclitaxel compared to the current standard first-line induction chemotherapy GP (gemcitabine, cisplatin) regimen can further improve therapeutic effects in high-risk patients with locally advanced disease. There is still a lack of head-to-head studies for comparison. This study aims to compare, through a prospective, parallel-controlled, randomized, open-label, multicenter phase II clinical trial, the TPC induction chemotherapy vs. the GP induction chemotherapy combined with concurrent chemoradiotherapy for the treatment of high-risk locoregionally advanced NPC (T4 or N2-3) in terms of 2-year progression-free survival, overall survival, overall response rate, toxic side effects, etc., conditionsModule conditions: Nasopharyngeal Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 162, type: ESTIMATED, armsInterventionsModule interventions name: TPC induction chemotherapy, interventions name: GP induction chemotherapy, outcomesModule primaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Distant progression, secondaryOutcomes measure: Locoregional progression, secondaryOutcomes measure: Short-term response rate, secondaryOutcomes measure: Incidence of acute and late toxicity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-sen University Cancer Center, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510060, country: China, contacts name: Hai-Qiang Mai, role: CONTACT, phone: 860-020-8734, phoneExt: 86-20-8734-364, email: maihq@sysucc.org.cn, contacts name: Hai-Qiang Mai, MD,PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, locations facility: Affiliated cancer hospital and institute of guangzhou medical university, status: NOT_YET_RECRUITING, city: Guangzhou, state: Please Select, zip: 510060, country: China, contacts name: Weijun Zhang, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: Sun Yat-Sen Memorial Hospital, status: NOT_YET_RECRUITING, city: Guangzhou, state: Please Select, zip: 510060, country: China, contacts name: Shoumin Bai, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: The First Affiliated Hospital of Guangzhou Medical University, status: NOT_YET_RECRUITING, city: Guangzhou, state: Please Select, zip: 510060, country: China, contacts name: Jiancong Sun, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: Dongguan people's hospital, status: NOT_YET_RECRUITING, city: Dongguan, country: China, contacts name: Zhigang Liu, role: CONTACT, geoPoint lat: 23.01797, lon: 113.74866, locations facility: Foshan First People's Hospital, status: NOT_YET_RECRUITING, city: Foshan, country: China, contacts name: Ning Zhang, role: CONTACT, geoPoint lat: 23.02677, lon: 113.13148, locations facility: Peking university shenzhen hospital, status: NOT_YET_RECRUITING, city: Shenzhen, country: China, contacts name: Yajie Liu, MD, role: CONTACT, geoPoint lat: 22.54554, lon: 114.0683, locations facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, status: NOT_YET_RECRUITING, city: Wuhan, country: China, contacts name: Kunyu Yang, role: CONTACT, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False