Nasopharyngeal Cancinoma (NPC), NPC Patients
Conditions
Keywords
NPC, proton radiotherapy, photon radiotherapy, proton beam therapy, IMPT, IMRT, IMAT, chemoradiation, Immune response, Radiomics
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.
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
Interventions
RADIATIONProton chemoradiotherapy
Concurrent chemoradiotherapy will be delivered using intensity modulated proton therapy, with a total dose of 69.96 CGE administered in 33 fractions.
RADIATIONPhoton 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.
Sponsors
Cheng-En Hsieh
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 2 years | Overall survival is defined as the time from signing the informed consent to death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | 2 years | 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 to progression | 2 years | Time to progression is defined as the time from signing the informed consent to the first occurrence of disease progression according to RECIST1.1. |
| Incidence and severity of adverse events | 5 years | Acute and late adverse events will be graded using CTCAE v5 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes of myeloid-derived suppressor cell levels | 4 months | 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. |
| Changes in MRI radiomic parameters | 4 months | 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) |
Countries
Taiwan
Contacts
Primary ContactRodney Cheng-En Hsieh, MD, PhD
Outcome results
None listed