Prospective Immuno-Radiomic Profiling in Nasopharyngeal Carcinoma Treated With Proton or Photon Chemoradiotherapy
Recruiting
Observational Study
NPC PatientsNasopharyngeal Cancinoma (NPC)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
500 (estimated)
Sponsor
Cheng-En Hsieh · Other
Who this trial is looking for
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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.
Trial Locations
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Status
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 r…
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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