NCT05622474

A Multicenter Randomized Controlled Clinical Study on the Treatment of T3N1M0 High Risk Nasopharyngeal Carcinoma With or Without Induction Chemotherapy Before Concurrent Radiotherapy and Chemotherapy

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 236 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare the efficacy and safety of curative radiotherapy with or without induction chemotherapy in patients with T3N1M0 nasopharyngeal carcinoma. The main question\[s\] it aims to answer are: * Whether induction chemotherapy confers a survival benefit in patients with T3N1M0 nasopharyngeal carcinoma with high risks factors. * Whether induction chemotherapy worsens adverse effects in patients with T3N1M0 nasopharyngeal carcinoma. Participants in experimental group will receive 3 cycles induction chemotherapy (GP or TPF) followed by concurrent chemoradiotherapy.Participants in control group will receive concurrent chemoradiotherapy only. Researchers will compare FFS, OS and AE or SAE to see if patients can benefit from induction chemotherapy or screen out high-risk factors associated with survival benefits.

Detailed description

In this study, 236 patients with pathologically diagnosed nasopharyngeal carcinoma and clinical stage of T3N1M0 will be randomly divided into two groups, 118 in the experimental group (induction chemotherapy + concurrent chemoradiotherapy) and 118 in the control group (concurrent chemoradiotherapy). The experimental group received 3 courses of induction chemotherapy followed by radical radiotherapy for the nasopharynx and neck, and 2-3 courses of cisplatin (100mg/m2, Q3W) treatment during radiotherapy. The control group received radical radiotherapy for the nasopharynx and neck, and 2-3 courses of cisplatin (100mg/m2, Q3W) during radiotherapy. Since there have been clinical trials to prove that GP or TPF induction chemotherapy is effective in locally advanced nasopharyngeal carcinoma, the induction chemotherapy regimen in this study can be selected by the investigator with GP or TPF. During treatment and within 3 years after treatment, the efficacy and safety of patients in both groups were followed up and evaluated.

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	Induction chemotherapy plus Concurrent chemotherapy	Induction chemotherapy: TP( Docetaxel 75mg/m2, D1 and cisplatin 25 mg/m2, D1-3 every 3 weeks for 3 cycles) OR GP (Gemcitabine 1000mg/m2，D1,D8 and cisplatin 25 mg/m2, D1-3 every 3 weeks for 3 cycles） Concurrent chemotherapy: DDP -- Cisplatin 25 mg/m2, D1-3 , every 3 weeks for 2 cycles during radiation.
DRUG	Concurrent chemotherapy	Concurrent chemotherapy: DDP -- Cisplatin 25 mg/m2, D1-3 , every 3 weeks for 2 cycles during radiation.
RADIATION	IMRT	Radical radiation: Intensity-modulated radiotherapy

Timeline

• Start date: 2022-11-30
• Primary completion: 2025-12-31
• Completion: 2028-12-31
• First posted: 2022-11-18
• Last updated: 2022-11-18

Locations

1 site across 1 country: China