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Phase III Non-Inferiority Trial: Reduced-Target vs. Full-Target IMRT After Chemo in Immunotherapy-Treated Metastatic Nasopharyngeal Cancer

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Collaborators: 16 to 15v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07188584
Lead Sponsor Ming-Yuan Chen
Collaborators: Fifth Affiliated Hospital, Sun Yat-Sen University, Cancer Hospital of Guangxi Medical University, Fujian Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine Central South University, Sun Yat-Sen University Cancer Center, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Zhejiang Cancer Hospital, West China Hospital, Xiangya Hospital of Central South University, Affiliated Cancer Hospital of Shantou University Medical College, Yunnan Cancer Hospital, First Affiliated Hospital of Kunming Medical University, Wuzhou Red Cross Hospital, Zhongshan People's Hospital, Guangdong, China, Southern Medical University, China
Conditions
(from sponsor)		 Nasopharyngeal Carcinoma (NPC)
Related terms Nasopharyngeal Carcinoma
Enrollment 166 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov