Zhongshan City People's Hospital
Zhongshan, Guangdong, 528403, China
Location status: Recruiting
NCT Number: NCT06282497
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
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Zhongshan, Guangdong, 528403, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-≥4 nodal regions of ipsilateral neck involvement;
neck CTV delineation extends from the lateral process of C1
neck CTV delineation extends from skull base
Time frame: 3 years
From the date of randomization to regional recurrence or any death
Time frame: 3 years
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
From the date of randomization to local recurrence or any death
Time frame: 3 years
From the date of randomization to distant metastasis or any death
Time frame: 3 years
From the date of randomization to local or regional recurrence, distant metastasis or any death
Time frame: From the start of treatment until 3 months post treatment
Assessed with CTCAE v5.0
Time frame: 3 years post treatment
Assessed with Radiation Therapy Oncology Group criteria and the CTCAE v5.0
Contact information is provided by the study sponsor or research team.
Zhongshan People's Hospital, Guangdong, China
Other
Xerostomia-optimised Intensity-modulated Radiotherapy Versus Standard Intensity-modulated Radiotherapy in Nasopharyngeal Carcinoma Patients:a Multicenter Non-inferior Randomized Controlled Phase III Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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