Actively Recruiting
Proton vs Photon IMRT in Locally Advanced Nasopharyngeal Carcinoma: A Phase III Trial
Led by Man Hu · Updated on 2026-01-14
300
Participants Needed
1
Research Sites
315 weeks
Total Duration
On this page
Sponsors
M
Man Hu
Lead Sponsor
S
Shandong Cancer Hospital and Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Proton vs Photon IMRT in Locally Advanced Nasopharyngeal Carcinoma: A Phase III Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years
- Histologically confirmed nasopharyngeal carcinoma (WHO type II or III)
- High-risk locoregionally advanced disease with clinical stage T4 or N3, M0 (no distant metastasis) according to AJCC staging
- No previous anti-tumor therapy for nasopharyngeal carcinoma
- ECOG performance status of 0 or 1
- Adequate organ function as defined by the study
- Eligible for induction chemotherapy followed by concurrent chemoradiotherapy combined with immunotherapy
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Evidence of distant metastasis (M1 disease)
- Prior radiotherapy, chemotherapy, targeted therapy, or immunotherapy for nasopharyngeal carcinoma
- Active autoimmune disease needing systemic treatment
- Uncontrolled infection or severe other health conditions affecting treatment tolerance
- Pregnancy or breastfeeding
- Known allergy or contraindication to study medications
- Any condition that makes participation unsuitable according to the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Jinan, Shandong, China, 250117
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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