Integrated Prospective Analysis of Radiomic and Immunologic Signatures in Nasopharyngeal Carcinoma Treated With Proton or Photon Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
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.
详细描述
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:
- 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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willingness to provide written informed consent.
- •Pathologically confirmed diagnosis of nasopharyngeal carcinoma
- •Age ≥18 years
- •ECOG performance status 0-1
- •Patients with AJCC v.9 stage I-III disease who undergo chemoradiotherapy
- •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
排除标准
- •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
- •Presence of severe major organ dysfunction
- •Pregnant women or women of childbearing potential who are unwilling to use medically acceptable contraception.
结局指标
主要结局
Overall survival
时间窗: 2 years
Overall survival is defined as the time from signing the informed consent to death from any cause.
次要结局
- Progression free survival(2 years)
- Time to progression(2 years)
- Incidence and severity of adverse events(5 years)
研究者
Cheng-En Hsieh
Associate Professor
Chang Gung Memorial Hospital