Proton vs Photon IMRT in Locally Advanced Nasopharyngeal Carcinoma: A Phase III Trial
ConditionNasopharyngeal Carcinoma (NPC)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMan Hu
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Intensity-Modulated Proton Therapy (IMPT)
- Intensity-Modulated Radiation Therapy (IMRT)
- Cisplatin
- Toripalimab
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Man Hu
Lead sponsor
Shandong Cancer Hospital and Institute
Sponsor institution
Shandong Cancer Hospital and Institute
Collaborator
Source ClinicalTrials.gov