Actively Recruiting
Phase III Non-Inferiority Trial of Proton Versus Photon Therapy for Nasopharyngeal Carcinoma
Led by Man Hu · Updated on 2025-06-03
386
Participants Needed
1
Research Sites
199 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a prospective, open-label, multicenter, cohort, phase III non-inferiority clinical trial comparing proton therapy with photon radiotherapy for nasopharyngeal carcinoma. It intends to enroll histologically confirmed newly diagnosed nasopharyngeal carcinoma patients without distant metastasis (M0). Through a prospective 1:1 matched cohort study design, patients will be divided into the intensity-modulated proton therapy (IMPT) group and the intensity-modulated radiation therapy (IMRT) group. Systemic treatment regimens are formulated according to clinical guidelines.
CONDITIONS
Official Title
Phase III Non-Inferiority Trial of Proton Versus Photon Therapy for Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent before any trial procedures
- Age between 18 and 75 years, any gender
- Histologically confirmed nasopharyngeal carcinoma (keratinizing, non-keratinizing differentiated, or undifferentiated)
- Clinical diagnosis of nasopharyngeal carcinoma (cT1-4N0-3M0, AJCC 9th edition)
- No prior systemic anti-tumor therapy for locally advanced disease
- ECOG performance status of 0 or 1
- Adequate organ function including: ANC 61.5x10^9/L, platelets 675x10^9/L, hemoglobin 659 g/dL, AST and ALT 642.5xULN, serum creatinine 641.5xULN and creatinine clearance 6560 ml/min
- Normal coagulation function and myocardial enzyme levels without clinical significance
You will not qualify if you...
- Presence of distant metastatic lesions (M1)
- Head and neck squamous cell carcinoma not originating from the nasopharynx
- Pathological types other than nasopharyngeal keratinizing and non-keratinizing carcinoma
- Participation in another interventional clinical trial
- Contraindications to radiotherapy
- Active hepatitis B infection with HBV-DNA above normal limits, except controlled cases with low viral load and therapy
- Active hepatitis C infection
- Pregnant women
- Severe or uncontrolled systemic diseases including serious cardiac arrhythmias, unstable angina, congestive heart failure (NYHA 61 Class 2), recent arterial thrombosis or embolism, active interstitial lung disease, active tuberculosis, active infections requiring systemic treatment, active diverticulitis or gastrointestinal obstruction, severe liver diseases, and mental disorders preventing cooperation
- Any medical condition deemed unsuitable by the investigator for study participation
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, China, 250117
Actively Recruiting
Research Team
M
Man Hu, Dr
CONTACT
W
Wanqi Zhu, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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