Condition: Nasopharyngeal Carcinoma (NPC) · Sponsor: Man Hu
This multicenter, open-label, randomized Phase III trial evaluates intensity-modulated proton therapy (IMPT) versus intensity-modulated photon radiotherapy (IMRT) in patients with newly diagnosed, high-risk, locoregionally advanced nasopharyngeal carcinoma. All patients receive induction chemotherapy followed by concurrent chemoradiotherapy combined with immunotherapy and are randomized 1:1 to IMPT or IMRT during the concurrent treatment phase. The primary endpoints are the incidence of grade ≥3 acute treatment-related toxicities and the 3-year progression-free survival (PFS) rate. Secondary endpoints include overall survival, locoregional relapse-free survival, distant metastasis-free survival, objective response rate, late toxicities, and quality of life.
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| Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences | Jinan, Shandong, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07340515