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Phase III Non-Inferiority Trial: Reduced-Target vs. Full-Target IMRT After Chemo in Immunotherapy-Treated Metastatic Nasopharyngeal Cancer
Sponsor: Ming-Yuan Chen
Summary
In order to further verify the effectiveness of the new prevention irradiation model for low-risk areas for nasopharyngeal carcinoma under immunotherapy, our team intends to conduct a non-inferiority clinical trial. The aim is to evaluate the efficacy and safety of two treatment modalities - local region reduced-target radiotherapy versus full-target radiatiotherapy (with/without CTV2) for newly diagnosed distant metastasis nasopharyngeal carcinoma, based on the full-course immunotherapy and full-dose chemotherapy. The primary endpoints are 2-year PFS and the incidence of grade 3 or higher radiation-related adverse events. If non-inferiority is confirmed, a new standard of "immunotherapy combined with reduced-target radiotherapy" will be established, ensuring efficacy while significantly reducing toxicity, and providing a more optimal comprehensive treatment strategy for nasopharyngeal carcinoma.
Official title: A Multicenter, Phase III Non-Inferiority Clinical Trial: Locoregional Volume-Reduction Versus Conventional Definitive Target IMRT Following Full-Dose Chemotherapy for Treatment-Naïve Distant Metastatic Nasopharyngeal Carcinoma Undergoing Full-Course Immunotherapy
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
166
Start Date
2025-08-20
Completion Date
2031-07-01
Last Updated
2025-12-09
Healthy Volunteers
No
Conditions
Interventions
Reduced-Target Radiotherapy
Experimental group: GTVnx: 69.96 Gy/33 Fr/2.12 Gy; GTVnd: 69.96 Gy/33 Fr/2.12 Gy; CTV1: 60.60 Gy/33 Fr/1.82 Gy; GTV2: No prescription dose (only delineated, actual dose is scattered dose).
Conventional Full-Target Radiotherapy
Control group: GTVnx: 69.96 Gy/33 F/2.12 Gy; GTVnd: 69.96 Gy/33 F/2.12 Gy; CTV1: 59.4 Gy/33 F/1.8 Gy; CTV2: 54 Gy/33 F/1.64 Gy.
Locations (1)
The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, Guangdong 519000 Recruiting
Zhuhai, China