In this multicenter, prospective, randomized, controlled, non-inferiority Phase III clinical trial, treatment-naïve patients with nasopharyngeal carcinoma (NPC) without metastasis will be enrolled for curative radiotherapy. The participants will be randomly assigned to two groups. The experimental group will receive online adaptive radiotherapy (ART) during the radiotherapy process, with a smaller PTV margin, while the control group will use original treatment plan during full-course radiotherapy, with a PTV margin of 3 mm. The study aims to compare the survival, adverse events, and quality of survival between the two groups, with the primary endpoint being the locoregional recurrence-free survival rate. The main objective is to determine the role of online ART in nasopharyngeal carcinoma, elucidating its potential to alleviate radiation toxicity in patients while ensuring treatment efficacy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
494
Radiation: Complete the full course of radiotherapy using the original treatment plan. Planning target volume (PTV) margin: 3mm;
Chemotherapy: If given, platinum-based.
Radiation: During the course of radiotherapy, the treatment plan is adjusted online based on the anatomical and dosimetric changes in the target volumes and organs at risk of patients. planning target volume (PTV) margin: smaller.
Chemotherapy: If given, platinum-based
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGLocoregional recurrence-free survival
locoregional progression free survival
Time frame: 3-year
Overall survival
overall survival
Time frame: 3-year
Distant metastasis free survival
Distant metastasis free survival
Time frame: 3-year
Rate of acute radiation-induced events according to Common Terminology Criteria for Adverse Events (CTCAE 5.0)
Acute radiation-induced events. The minimum and maximum values are 0 and 5 respectively. The higher scores mean a worse outcome.
Time frame: 3 months
Rate of late radiation-induced events according to Common Terminology Criteria for Adverse Events (CTCAE 5.0).
Late radiation-induced events. The minimum and maximum values are 0 and 5 respectively. The higher scores mean a worse outcome.
Time frame: 3-year
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck 35 Version 1.0 (EORTC QLQ-HN35 V1.0)
The minimum and maximum values are 0 and 4 respectively. The higher scores mean a worse outcome.
Time frame: From baseline to 3 years post-radiotherapy
and National Cancer Institute Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events Version 1.0 (NCI-PRO-CTCAE V1.0.)
The minimum and maximum values are 0 and 5 respectively. The higher scores mean a worse outcome.
Time frame: From baseline to 3 years post-radiotherapy
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