nctId: NCT06301165 id: 2023-FXY-129 briefTitle: TPC Versus GP Induction Chemotherapy for Nasopharyngeal Carcinoma overallStatus: RECRUITING date: 2024-03-19 date: 2024-12-31 date: 2028-12-31 date: 2024-03-08 date: 2024-04-09 name: Sun Yat-sen University class: OTHER 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. conditions: Nasopharyngeal Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 162 type: ESTIMATED name: TPC induction chemotherapy name: GP induction chemotherapy measure: Progression-free survival measure: Overall survival measure: Distant progression measure: Locoregional progression measure: Short-term response rate measure: Incidence of acute and late toxicity sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen University Cancer Center status: RECRUITING city: Guangzhou state: Guangdong zip: 510060 country: China name: Hai-Qiang Mai role: CONTACT phone: 860-020-8734 phoneExt: 86-20-8734-364 email: maihq@sysucc.org.cn name: Hai-Qiang Mai, MD,PhD role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 facility: Affiliated cancer hospital and institute of guangzhou medical university status: NOT_YET_RECRUITING city: Guangzhou state: Please Select zip: 510060 country: China name: Weijun Zhang role: CONTACT lat: 23.11667 lon: 113.25 facility: Sun Yat-Sen Memorial Hospital status: NOT_YET_RECRUITING city: Guangzhou state: Please Select zip: 510060 country: China name: Shoumin Bai role: CONTACT lat: 23.11667 lon: 113.25 facility: The First Affiliated Hospital of Guangzhou Medical University status: NOT_YET_RECRUITING city: Guangzhou state: Please Select zip: 510060 country: China name: Jiancong Sun role: CONTACT lat: 23.11667 lon: 113.25 facility: Dongguan people's hospital status: NOT_YET_RECRUITING city: Dongguan country: China name: Zhigang Liu role: CONTACT lat: 23.01797 lon: 113.74866 facility: Foshan First People's Hospital status: NOT_YET_RECRUITING city: Foshan country: China name: Ning Zhang role: CONTACT lat: 23.02677 lon: 113.13148 facility: Peking university shenzhen hospital status: NOT_YET_RECRUITING city: Shenzhen country: China name: Yajie Liu, MD role: CONTACT lat: 22.54554 lon: 114.0683 facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology status: NOT_YET_RECRUITING city: Wuhan country: China name: Kunyu Yang role: CONTACT lat: 30.58333 lon: 114.26667 hasResults: False