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

ConditionsNPC Patients Nasopharyngeal Cancinoma (NPC)

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorCheng-En Hsieh

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Willingness to provide written informed consent.

Pathologically confirmed diagnosis of nasopharyngeal carcinoma

Age ≥18 years

ECOG performance status 0-1

Disqualifiers

Presence of distant metastasis

Patients with AJCC v.9 cT1N0M0 disease who undergo radiotherapy alone.

Synchronous or prior invasive malignancy, unless disease-free for at least 2 years.

Prior radiotherapy to the head and neck region

Trial population

Patients with AJCC 9th edition stage I-III nasopharyngeal carcinoma undergoing definitive chemoradiotherapy using either proton or photon radiotherapy.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Proton chemoradiotherapy
Radiation
Concurrent chemoradiotherapy will be delivered using intensity modulated proton therapy, with a total dose of 69.96 CGE administered in 33 fractions.
Photon chemoradiotherapy
Radiation
Concurrent chemoradiotherapy will be delivered using photon-based volumetric modulated arc therapy, with a total dose of 69.96 Gy administered in 33 fractions.

Treatment groups

500 Participants

are divided into 2 treatment groups

Group A: Proton chemoradiotherapy1 intervention

Group B: Photon chemoradiotherapy1 intervention

Trial outcomes

Primary outcomes

Overall survival

Overall survival is defined as the time from signing the informed consent to death from any cause.

Time frame

2 years

Secondary outcomes

Progression free survival

Progression free survival is defined as the time from signing the informed consent to the first occurrence of disease progression or death from any cause (whichever occurs first) according to RECIST1.1

Time frame

2 years

Time to progression

Time to progression is defined as the time from signing the informed consent to the first occurrence of disease progression according to RECIST1.1.

Time frame

2 years

Incidence and severity of adverse events

Acute and late adverse events will be graded using CTCAE v5

Time frame

5 years

Other outcomes

Changes of myeloid-derived suppressor cell levels

The levels of myeloid-derived suppressor cells (MDSCs) in peripheral blood will be analyzed at baseline, 6-8 weeks, and 3-4 months following the initiation of radiotherapy.

Time frame

4 months

Changes in MRI radiomic parameters

Radiomic features will be extracted from MRI obtained pre-treatment and at 3-4 months post-chemoradiotherapy; feature changes will be computed as absolute (Δf = fpost - fpre) and percent change (Δ% = 100 × (fpost - fpre) / fpre)

Time frame

4 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cheng-En Hsieh

Lead sponsor

Chang Gung Memorial Hospital

Sponsor institution

Source ClinicalTrials.gov

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