Fujian Cancer hospital
Fuzhou, Fujian, 351100, China
Location contact
Qiaojuan Guo, DR
CONTACT
NCT Number: NCT07268690
This is a randomized, phase III, prospective, multi-center trial in newly diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. This study will evaluate whether omitting Level Va irradiation in patients without these risk features does not compromise regional control or survival, with the goal of providing robust evidence to guide further personalization of NPC radiotherapy.
Trial opening soon.
Get Notified18 year–70 year
All sexes
Interventional
Phase 3
Fuzhou, Fujian, 351100, China
Qiaojuan Guo, DR
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Level Va should be irradiated only in the presence of any of the following high-risk features: 1. Ipsilateral Level IIb involvement; 2. Ipsilateral Level III nodes involvement; 3. Ipsilateral positive lymph nodes below the cricoid cartilage (Level IV or Vb-c).
Time frame: 3 years
The regional relapse-free survival rate will be estimated using Kaplan-Meier method for each arm from the date of randomization to the date of nodal relapse or death from any cause, whichever occurred first. Their differences will be compared between treatment arms using the log-rank test.
Time frame: 3 years
time from the date of the start of chemotherapy to death due to any cause
Time frame: 3 years
The distant metastasis-free survival rate will be estimated using Kaplan-Meier
Time frame: 3 years
until documented treatment local failure or death from any cause.
Time frame: 3 years
European Organization for Research and Treatment of Cancer Quality-of-Life Head and Neck Questionnaire
Contact information is provided by the study sponsor or research team.
Fujian Cancer Hospital
Other Gov
Risk-Adapted Omission of Level Va Irradiation in Nasopharyngeal Carcinoma: A Phase III Randomized Non-Inferiority 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.