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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
Sponsor: Sun Yat-sen University
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.
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
236
Start Date
2022-11-30
Completion Date
2028-12-31
Last Updated
2022-11-18
Healthy Volunteers
No
Conditions
Interventions
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.
Concurrent chemotherapy
Concurrent chemotherapy: DDP -- Cisplatin 25 mg/m2, D1-3 , every 3 weeks for 2 cycles during radiation.
IMRT
Radical radiation: Intensity-modulated radiotherapy
Locations (1)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China