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Recruiting NCT07232680

Prospective Immuno-Radiomic Profiling in Nasopharyngeal Carcinoma Treated With Proton or Photon Chemoradiotherapy

Trial Parameters

Condition NPC Patients
Sponsor Cheng-En Hsieh
Study Type OBSERVATIONAL
Phase N/A
Enrollment 500
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-11-20
Completion 2031-08-15
Interventions
Proton chemoradiotherapyPhoton chemoradiotherapy

Brief Summary

To prospectively investigate and integrate radiomic and immunologic signatures in patients with nasopharyngeal carcinoma (NPC) treated with either proton or photon radiotherapy, with the aim of identifying biomarkers associated with treatment response, toxicity, and long-term outcomes.

Eligibility Criteria

Inclusion Criteria: 1. Willingness to provide written informed consent. 2. Pathologically confirmed diagnosis of nasopharyngeal carcinoma 3. Age ≥18 years 4. ECOG performance status 0-1 5. Patients with AJCC v.9 stage I-III disease who undergo chemoradiotherapy 6. Adequate bone marrow, liver, and renal function within 4 weeks before study registration * Hemoglobin ≥ 9.0 g/dL * Absolute neutrophil count (ANC) ≥ 1,000/mm3 * Platelet count ≥ 50,000/μL * Total bilirubin \< 2.5 mg/dL * Serum albumin \>2.8 g/dL * Serum creatinine ≤ 1.5 mg/dL Exclusion Criteria: 1. Presence of distant metastasis 2. Patients with AJCC v.9 cT1N0M0 disease who undergo radiotherapy alone. 3. Synchronous or prior invasive malignancy, unless disease-free for at least 2 years. 4. Prior radiotherapy to the head and neck region 5. Presence of severe major organ dysfunction 6. Pregnant women or women of childbearing potential who are unwilling to use medically acceptable contraception.

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