The goal of this multicenter randomized non-inferior study is to compare radiotherapy alone versus concurrent chemoradiotherapy in locally advanced nasopharyngeal carcinoma patients whose EBV DNA drop to undetectable level after one cycle neoadjuvant chemotherapy using GP regimen. The main question it aims to answer is: the omission of concurrent chemotherapy is safe in the relatively good prognostic patients identified by the response of EBV DNA. Participants will be randomized to either radiotherapy alone or the standard treatment concurrent chemoradiotherapy if their EBV DNA decrease to undetectable level post first cycle of neoadjuvant chemotherapy and don't rebound in the second and third cycle.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
366
IMRT for primary and regional field
Cisplatin 80mg/m2, 21days/cycle, 2 cycles
Fudan Universtiy Shanghai Cancer Centre
Shanghai, Shanghai Municipality, China
RECRUITINGProgression-free survival
Defined from date of randomization to date of first documentation of progression or death due to any cause
Time frame: 2 years
Overall survival
Defined from date of randomization to date of first documentation of death from any cause or censored at the date of the last follow-up.
Time frame: 2 years
Toxicities
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.
Time frame: 2 years
change of quality of life
QoL scores were assessed for each scale by using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTCQLQ-C30) before induction chemotherapy, before radiotherapy, at the end of radiotherapy, at 3 months after radiotherapy, at 6 months after radiotherapy and 12 months after radiotherapy
Time frame: 1 year
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