RecruitingPhase 2NCT06301165

TPC Versus GP Induction Chemotherapy for Nasopharyngeal Carcinoma

TPC Versus GP Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for High-risk Locoregionally Advanced Nasopharyngeal Carcinoma, a Multi-center Phase II Randomized Trial


Sponsor

Sun Yat-sen University

Enrollment

162 participants

Start Date

Mar 19, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study compares two chemotherapy combinations used before the main treatment for people with locally advanced nasopharyngeal carcinoma (a cancer found at the back of the nose and throat). One combination is TPC (taxane, platinum, capecitabine) and the other is GP (gemcitabine, platinum). Researchers want to find out which approach shrinks tumors more effectively and with better tolerability before radiation therapy. **You may be eligible if...** - You are between 18 and 65 years old - You have a confirmed diagnosis of nasopharyngeal carcinoma (WHO type II or III) - Your cancer is locally advanced (stage T4 or with significant lymph node involvement) with no distant spread - You are in good general health (ECOG score 0–1) - Your blood counts, liver, and kidney function are within acceptable ranges **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have significant heart, liver, kidney, or hearing problems - You are pregnant or breastfeeding - You have already received treatment for this cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTPC induction chemotherapy

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).

DRUGGP induction chemotherapy

GP induction chemotherapy regimen (gemcitabine 1000 mg/m2 D1/8, cisplatin 80 mg/m2 D1, every 3 weeks for 3 cycles)


Locations(8)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Affiliated cancer hospital and institute of guangzhou medical university

Guangzhou, Please Select, China

Sun Yat-Sen Memorial Hospital

Guangzhou, Please Select, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Please Select, China

Dongguan people's hospital

Dongguan, China

Foshan First People's Hospital

Foshan, China

Peking university shenzhen hospital

Shenzhen, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

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NCT06301165


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