This study investigates whether administering reduced dose is non-inferior to standard dose radiotherapy in terms of 3-year locoregional relapse-free survival (LRRFS) rate for stage I nasopharyngeal carcinoma patients who are sensitive to radiotherapy.
Age 18-70, regardless of sex.
Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of WHO II or III, clinical stage I (according to the 9th American Joint Committee on Cancer[AJCC] edition).
Patients with CR according to RECIST and EBV DNA undetectable after received 50.88Gy radiation.
ECOG (Eastern Cooperative Oncology Group) score: 0-1.
Histologically confirmed keratinizing squamous cell carcinoma (WHO I).
Patients with PR/SD/PD according to RECIST and/or EBV DNA detectable after received 50.88Gy radiation.
Receiving radiotherapy or chemotherapy or targeted therapy previously.
Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
Parallel
Reduced dose radiation
RadiationReduced dose group would receive 61.48Gy radiation.
Standard dose radiation
RadiationStandard dose group would receive 69.96Gy radiation.
Locoregional relapse-free survival
The time from randomization to either documented local and/or regional relapse or death from any cause,whichever occurred first.
Progression-free survival
Time from randomisation to any documented local or regional relapse, distant metastasis, or death from any cause, whichever occurr first.
Overall survival
Time from randomisation to death from any cause or censored at the date of the last follow-up.
Distant metastasis-free survival
Time from randomistion to distant metastasis or death from any cause.
Incidence rate of adverse events (AEs)
Analysis of acute and late adverse events (AEs) are evaluated. Numbers of patients of treatment-related adverse events(acute toxicity) as assessed by CTCAE v5.0.Numbers of patients of late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme.
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Hai-Qiang Mai,MD,PhD
Lead sponsor
Sun Yat-sen University
Sponsor institution
