Xerostomia-optimised IMRT Versus Standard IMRT in NPC

Официальное название

Xerostomia-optimised Intensity-modulated Radiotherapy Versus Standard Intensity-modulated Radiotherapy in Nasopharyngeal Carcinoma Patients:a Multicenter Non-inferior Randomized Controlled Phase III Clinical Trial

Обзор

This is a multi-center, non-inferiority, open-label, randomized controlled phase III clinical trial in primary diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. This study aims to compare the regional control, survival outcomes, radiation-related toxicities, and quality of life (QoL) of xerostomia-optimized intensity-modulated radiotherapy versus standard intensity-modulated radiotherapy in NPC patients

Подробное описание

Xerostomia remains one of the most common radiation-induced toxicities, and approximately 80% to 90% of NPC patients still experience varying degrees of xerostomia post-IMRT. Among the major salivary glands, the parotid gland is the largest and produces 60% to 65% of the oral saliva output. Studies have revealed that xerostomia post-IMRT is mainly dependent on the irradiation dose of the parotid glands. Clinical target volumes (CTV) for the cervical nodal region starting from skull base have been the standard in nasopharyngeal carcinoma for several decades. Consequently, the parotid glands overlap with the target volumes and irradiation dose reaches 31.7 Gy to 43.9 Gy in most reports. Retrospective studies reveal that the lateral process of C1 is a suitable cranial edge for neck CTV delineation; therefore, the volume of the parotid glands exposed to high radiation doses can be greatly reduced. we conducted this trial comparing outcomes ,toxicities and QoL of xerostomia-optimized intensity-modulated radiotherapy versus standard intensity-modulated radiotherapy in nasopharyngeal carcinoma.

Вмешательства

• Лучевая терапия Optimised neck CTV
  neck CTV delineation extends from the lateral process of C1
• Лучевая терапия standard neck CTV
  neck CTV delineation extends from skull base

Первичные конечные точки

• Regional recurrence free survival [Срок оценки: 3 years]

Вторичные конечные точки (6)

• Overall survival [Срок оценки: 3 years]
• Local recurrence free survival [Срок оценки: 3 years]
• Distant metastasis-free survival [Срок оценки: 3 years]
• Progression free survival [Срок оценки: 3 years]
• Acute toxicities [Срок оценки: From the start of treatment until 3 months post treatment]
• Late toxicities [Срок оценки: 3 years post treatment]

Критерии участия

Критерии включения

• Newly histologic diagnosis of nasopharyngeal non-keratinizing carcinoma (WHO II/III);
• All genders, range from 18-70 years old;
• ECOG score 0-1;
• Clinical stage I-IVa (AJCC/UICC 8th);
• Not received radiotherapy, chemotherapy and other anti-tumor treatment (including immunotherapy);
• No contraindications to chemotherapy or radiotherapy;
• Adequate organ function: white blood cell count ≥ 4×109/L, neutrophile granulocyte count ≥ 1.5×109/L, hemoglobin ≥ 90g/L, platelet count ≥ 100×109/L; alanine aminotransferase or aspartate aminotransferase < 2.5×upper limit of normal; blood urea nitrogen or creatinine ≤ 1.5×upper limit of normal or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
• Sign the consent form.

Критерии исключения

• Level II involvement with extracapsular extension (ECE), and/or had a maximum nodal axial diameter (MAD) of greater than 3cm in level II ;

-≥4 nodal regions of ipsilateral neck involvement;

• Radiologically suspicious or confirmed involvement in level II area between skull base and the lateral process of C1;
• Parotid lymph node and/or parotid gland involvement;
• History of parotid disease or surgery;
• Previous malignancy or other concomitant malignant disease;
• Pregnancy or lactation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Zhongshan City People's Hospital — Zhongshan

Идентификаторы

NCT: NCT06282497 · ZSCPH-003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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