An interventional study of Optimised neck CTV and standard neck CTV in Nasopharyngeal Carcinoma ,Xerostomia,Radiotherapy, sponsored by Zhongshan People's Hospital, Guangdong, China. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-05-01.
Sponsored by Zhongshan People's Hospital, Guangdong, China · Not applicable, Interventional, and Treatment
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
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.
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;
optimised neck CTV delineation
Radiation: Optimised neck CTV
standard neck CTV delineation
Radiation: standard neck CTV
neck CTV delineation extends from the lateral process of C1
neck CTV delineation extends from skull base
Regional recurrence free survival
From the date of randomization to regional recurrence or any death
Time frame: 3 years
Overall survival
From the date of randomization to any death, with patients unavailable for follow-up censored at the date of last follow-up
Time frame: 3 years
Local recurrence free survival
From the date of randomization to local recurrence or any death
Time frame: 3 years
Distant metastasis-free survival
From the date of randomization to distant metastasis or any death
Time frame: 3 years
Progression free survival
From the date of randomization to local or regional recurrence, distant metastasis or any death
Time frame: 3 years
Acute toxicities
Assessed with CTCAE v5.0
Time frame: From the start of treatment until 3 months post treatment
Late toxicities
Assessed with Radiation Therapy Oncology Group criteria and the CTCAE v5.0
Time frame: 3 years post treatment
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Zhongshan People's Hospital, Guangdong, China