Prospective Immuno-Radiomic Profiling in Nasopharyngeal Carcinoma Treated With Proton or Photon Chemoradiotherapy
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Proton chemoradiotherapy, Photon chemoradiotherapy.
- Кому может быть актуально
- Состояния в реестре: NPC Patients, Nasopharyngeal Cancinoma (NPC). Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Тайвань
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Integrated Prospective Analysis of Radiomic and Immunologic Signatures in Nasopharyngeal Carcinoma Treated With Proton or Photon Radiotherapy
Обзор
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.
Подробное описание
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
Вмешательства
- Лучевая терапия Proton chemoradiotherapy
Concurrent chemoradiotherapy will be delivered using intensity modulated proton therapy, with a total dose of 69.96 CGE administered in 33 fractions. - Лучевая терапия 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.
Первичные конечные точки
- Overall survival [Срок оценки: 2 years]
Вторичные конечные точки (3)
- Progression free survival [Срок оценки: 2 years]
- Time to progression [Срок оценки: 2 years]
- Incidence and severity of adverse events [Срок оценки: 5 years]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Тайвань · 1 центр
- Chang Gung Memorial Hospital at Linkou — Taoyuan City
Идентификаторы
NCT: NCT07232680 · 202501031A3