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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
162
TPC induction chemotherapy regimen contains Polymeric micellar paclitaxel, which is a novel Cremophor EL-free, nanoparticle micellar formulation of paclitaxel, cisplatin and capecitabine. TPC induction chemotherapy regimen (polymeric micellar paclitaxel 200 mg/m2 D1, cisplatin 75 mg/m2 D1, capecitabine 1000 mg/m2/day D1-14, every 3 weeks for 3 cycles).
GP induction chemotherapy regimen (gemcitabine 1000 mg/m2 D1/8, cisplatin 80 mg/m2 D1, every 3 weeks for 3 cycles)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGAffiliated cancer hospital and institute of guangzhou medical university
Guangzhou, Please Select, China
NOT_YET_RECRUITINGSun Yat-Sen Memorial Hospital
Guangzhou, Please Select, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Please Select, China
NOT_YET_RECRUITINGDongguan people's hospital
Dongguan, China
NOT_YET_RECRUITINGFoshan First People's Hospital
Foshan, China
NOT_YET_RECRUITINGPeking university shenzhen hospital
Shenzhen, China
RECRUITINGUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
RECRUITINGProgression-free survival
Defined as the time from random assignment to documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first.
Time frame: 2 years
Overall survival
Defined as the time from random assignment to death from any cause.
Time frame: 2 years
Distant progression
Defined as the time from random assignment to the occurrence of a distant progression. Cumulative incidence of distant progression will be calculated within a competing risk framework (Fine and Gray 1999).
Time frame: 2 years
Locoregional progression
Defined as the time from random assignment to the occurrence of a locoregional progression. Cumulative incidence of locoregional progression will be calculated within a competing risk framework (Fine and Gray 1999).
Time frame: 2 years
Short-term response rate
Tumour response was classified according to RECIST, version 1.1
Time frame: 32 weeks
Incidence of acute and late toxicity
Incidence of acute toxicity is evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) 5.0 criteria. Late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme. Acute adverse events, occurring during study treatment, and radiation-related late adverse events, occurring from 3 months after completion of radiotherapy, and chemotherapy-induced late adverse events, occurring from 3 months after completion of chemotherapy until end of follow up).
Time frame: 2 years
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