NCT07340515

Proton vs Photon IMRT in Locally Advanced Nasopharyngeal Carcinoma: A Phase III Trial

RecruitingPHASE3

Study summary

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.

At a glance

Conditions: Nasopharyngeal Carcinoma (NPC)
Interventions: Intensity-Modulated Proton Therapy (IMPT), Intensity-Modulated Radiation Therapy (IMRT), Cisplatin, Toripalimab
Lead sponsor: Man Hu
Target enrollment: 300 participants
Age: 18 Years – 70 Years
Sex: ALL
Locations: Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Registry: View on ClinicalTrials.gov ↗

Eligibility criteria

Inclusion Criteria: * Age 18 to 70 years * Histologically confirmed nasopharyngeal carcinoma (WHO type II or III) * High-risk locoregionally advanced disease defined as clinical stage T4 or N3, M0, according to the AJCC staging system * No prior anti-tumor therapy for nasopharyngeal carcinoma, including radiotherapy, chemotherapy, targeted therapy, or immunotherapy * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Adequate organ function as defined in the study protocol * Eligible to receive induction chemotherapy followed by concurrent chemoradiotherapy combined with immunotherapy as specified in the protocol * Ability to understand and willingness to sign written informed consent Exclusion Criteria: * Evidence of distant metastasis (M1 disease) * Prior radiotherapy, chemotherapy, targeted therapy, or immunotherapy for nasopharyngeal carcinoma * Active autoimmune disease requiring systemic therapy * Uncontrolled infection or severe comorbidities that may affect treatment tolerance * Pregnancy or breastfeeding * Known allergy, hypersensitivity, or contraindication to study medications as defined in the protocol * Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation