Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029, China
Location status: Recruiting
NCT Number: NCT06752239
This study is a multicenter, non-inferiority, open-label, randomized controlled Phase III clinical trial. It aims to compare the efficacy of modified delineation radiotherapy (experimental group) versus standard delineation radiotherapy (control group) in the prophylactic irradiation of neck lymphatic drainage areas III/IVa in nasopharyngeal carcinoma. The study evaluates the incidence of primary hypothyroidism, quality of life, and adverse events between the two groups.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Phase 3
Nanchang, Jiangxi, 330029, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Modified delineation (MD) of cervical lymphatic drainage areas, sparing the common carotid artery within the clinical target volume (CTV)
Other names: MD
Standard delineation
Time frame: 3 years
Regional Recurrence-Free Survival (RRFS) is defined as the time interval from the date of randomization to the date of lymph node failure in the cervical lymphatic drainage area or the last follow-up date.
Time frame: 3 years
Overall Survival (OS) is defined as the time interval from the date of randomization to the date of death from any cause or the last follow-up date.
Time frame: 3 years
Disease-Free Survival (DFS) is defined as the time interval from the date of randomization to the date of tumor recurrence or death from any cause.
Time frame: 3 years
Hypothyroidism-free survival is defined as the time interval from the date of randomization to the date of the first occurrence of hypothyroidism or the last follow-up date.
Time frame: 3 years
Clinical hypothyroidism-free survival is defined as the time interval from the date of randomization to the date of the first occurrence of clinical hypothyroidism or the last follow-up date.
Time frame: 1year, 2 year and 3 years
The quality of life of patients in the two groups will be assessed using the EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30).
Contact information is provided by the study sponsor or research team.
Jiangxi Provincial Cancer Hospital
Other
Prophylactic Radiotherapy Optimization for Enhanced Thyroid Function Protection in Nasopharyngeal Carcinoma (PROTECT-NPC): A Multicenter, Non-Inferiority, Open-Label, Randomized Controlled Phase III Clinical Trial
Acronym: PROTECT-NPC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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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