Find Nasopharyngeal Carcinoma Clinical Trials Near You
40.2Gy Versus 49.2Gy Radiotherapy in Low-Risk Target Volume for Chemosensitive Stage II Nasopharyngeal Carcinoma Under Full-Course Immunotherapy: a Multicentre, Randomised, Phase 3 Trial
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This study aims to explore the efficacy and adverse events of reduced-dose radiotherapy (40.2Gy) versus conventional-dose radiotherapy (49.2Gy) to low-risk target volume for chemosensitive intermediate-stage nasopharyngeal carcinoma patients.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Patients are informed of the basic content of this study and sign an informed consent form;
• Age between 18 and 75 years;
• Pathologically diagnosed as non-keratinising nasopharyngeal carcinoma (differentiated or undifferentiated, i.e., WHO type II or III);
• Staged according to the 9th edition of the AJCC/UICC TNM classification as T1-3N2M0 or T3N0-1M0 (Stage II);
• KPS ≥ 70;
• Normal bone marrow function: WBC ≥ 4 × 10⁹/L, PLT ≥ 100 × 10⁹/L, HGB ≥ 90 g/L;
• Imaging evaluation of treatment response after three cycles of GPP/TPP induction chemotherapy plus immunotherapy: CR or PR;
• Plasma EBV DNA level decreases to 0 copies/mL or below the detection limit after induction chemotherapy;
• Normal liver and kidney function: total bilirubin, AST, ALT ≤ 2.0 times the upper limit of normal, creatinine clearance ≥ 60 mL/min or creatinine ≤ 1.5 times the upper limit of normal.
Locations
Other Locations
China
Central South University Cancer Hospital,
RECRUITING
Changsha
Xiangya Hospital of Central South University
RECRUITING
Changsha
West China Hospital, Sichuan University
RECRUITING
Chengdu
Fujian Cancer Hospital
RECRUITING
Fuzhou
Sun Yat-sen University cancer center
RECRUITING
Guangzhou
the Affiliated Cancer Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Anhui Provincial Cancer Hospital
RECRUITING
Hefei
The First Affiliated Hospital of Kunming Medical University
RECRUITING
Kunming
Yunnan Cancer Hospital
RECRUITING
Kunming
Guangxi Medical University Cancer Hospital
RECRUITING
Nanning
Cancer Hospital of Shantou University Medical College
RECRUITING
Shantou
Wuzhou Red Cross Hospital
RECRUITING
Wuzhou
Zhongshan City People's Hospital
RECRUITING
Zhongshan
The Fifth Affiliated Hospital of Sun Yat-sen University
RECRUITING
Zhuhai
Contact Information
Primary
Ming-Yuan Chen, MD,PhD
chenmy@sysucc.org.cn
+86-20-87343361
Backup
Rui You, MD,PhD
your5@mail.sysu.edu.cn
+86-13580439820
Time Frame
Start Date:2025-11-20
Estimated Completion Date:2032-06-30
Participants
Target number of participants:346
Treatments
Experimental: Reduced-dose radiotherapy to CTV2 combined with full-course immunotherapy
Active_comparator: Conventional-dose radiotherapy to CTV2 combined with full-course immunotherapy