NCT07232680

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

Integrated Prospective Analysis of Radiomic and Immunologic Signatures in Nasopharyngeal Carcinoma Treated With Proton or Photon Radiotherapy

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Cheng-En Hsieh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a non-randomized, single-center, phase II prospective trial enrolling patients with stage I-III NPC undergoing definitive proton or photon chemoradiotherapy. Participants will be followed for ≥2 years after treatment completion to evaluate clinical outcomes and longitudinal biomarker dynamics, including radiomic and immunologic signatures. Radiotherapy target delineation was performed according to established consensus guidelines. The gross tumor volume (GTV) included all radiologically visible primary tumors and involved lymph nodes. The clinical target volume receiving 69.96 Gy encompassed the GTV with a 0-5 mm margin and may also include the entire nasopharynx. The clinical target volume receiving 59.4 Gy was optionally delineated at the discretion of the treating physician to encompass regions at high risk for microscopic disease spread, including the nasopharynx, nasal cavity, maxillary sinuses, pterygoid plates, parapharyngeal space, retropharyngeal lymph nodes, clivus, skull base, sphenoid sinus, and bilateral upper cervical lymph nodes. The elective neck volumes, receiving 50-54.12 Gy , encompassed the bilateral cervical lymphatic drainage regions. The detailed contour definitions followed the International Consensus Guidelines on Delineation of Clinical Target Volumes at Different Dose Levels for Nasopharyngeal Carcinoma. Concurrent Chemotherapy Regimens: 1. Cisplatin Based Regimens o Dosage: Cisplatin 100 mg/m² IV on Day 1 every 3 weeks during radiotherapy (total 2-3 cycles); Cisplatin 50 mg/m² IV on Day 1 every 2 weeks during radiotherapy (typically 6-8 weeks); Cisplatin 40 mg/m² IV weekly during radiotherapy (typically 6-7 weeks) 2. Carboplatin-Based Regimens o Dosage: Carboplatin AUC 5-6 IV every 3 weeks The use of induction chemotherapy is allowed in locally advanced NPC 1. TPF Regimen (Docetaxel + Cisplatin + 5-Fluorouracil) * Docetaxel: 75 mg/m² IV on Day 1 * Cisplatin: 75 mg/m² IV on Day 1 * 5-FU: 750-1000 mg/m²/day continuous IV infusion on Days 1-5 * Cycle: Every 3 weeks × 2-3 cycles 2. GP Regimen (Gemcitabine + Cisplatin) * Gemcitabine: 1000 mg/m² IV on Days 1 and 8 * Cisplatin: 80 mg/m² IV on Day 1 * Cycle: Every 3 weeks × 2-3 cycles 3. TP Regimen (Docetaxel + Cisplatin) * Docetaxel: 75 mg/m² IV on Day 1 * Cisplatin: 75 mg/m² IV on Day 1 * Cycle: Every 3 weeks × 2-3 cycles

Conditions

• NPC Patients
• Nasopharyngeal Cancinoma (NPC)

Interventions

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

Timeline

• Start date: 2025-11-20
• Primary completion: 2031-08-15
• Completion: 2034-08-15
• First posted: 2025-11-18
• Last updated: 2025-11-24

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated device study