🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT06282497
Recruiting Not applicable

Xerostomia-optimised IMRT Versus Standard IMRT in NPC

NCT06282497 · tracked via the Priya Life Science China tracker
Sponsor
Zhongshan People's Hospital, Guangdong, China
Phase
Not applicable
Started
2023-10-23
Last updated
2024-05-01

Condition(s) studied

Nasopharyngeal Carcinoma ,Xerostomia,Radiotherapy

Investigational drug(s) / intervention(s)

Optimised neck CTVstandard neck CTV

Optimised neck CTV: neck CTV delineation extends from the lateral process of C1

standard neck CTV: neck CTV delineation extends from skull base

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Zhongshan City People's Hospital Zhongshan Guangdong Recruiting

More Zhongshan People's Hospital, Guangdong, China trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06282497 on ClinicalTrials.gov ↗ ← All trials in China