The main objective of this trial was to determine the value of concurrent chemoradiotherapy for Intermediate-risk head and neck squamous cell carcinoma
Stages
white blood cell count > 4×109/L
hemoglobin > 120g/L in males, 110g/L in females
platelet count > 100×109/L
unstable heart disease that requires treatment
kidney disease
chronic hepatitis
poorly controlled diabetes (fasting blood glucose > 1.5×ULN)
Parallel
Cisplatin
DrugConcurrent Cisplatin chemotherapy (100 mg/m2 intravenous injection,once every 3 weeks, twice in total, on days 1 and 22) will be given plus intensity modulated radiotherapy
Failure-free survival (FFS)
calculated from enrolment to the date of locoregional recurrence,distant metastasis,or death from any cause, whichever occurred first.
Overall survival (OS)
calculated from enrolment to the date of death from any cause.
Distant metastasis-free survival(DMFS)
calculated from enrolment to the date of first distant metastasis.
locoregional recurrence-free survival (LRRFS)
calculated from enrolment to the date of locoregional persistence or 1st locoregional recurrence.
Quality of life (QoL)
The change of QoL from randomization to the start of radiotherapy,the end of radiotherapy,13-16 weeks after radiotherapy,2 years and 3 years after randomization. The EORTC QoL questionnaire-C30(EORTC quality of life questionnaire-C30#version 3.0 will be used. This questionnaire comprises 30 questions,24 of which are aggregated into nine multi- question scales,that is,five functioning scales (e.g.,physical),three symptom scales (e.g.,fatigue)and one global health status scale. The remaining six single-question (e.g.,dyspnoea)scales assess symptoms. These 15 scales will be scored according to the official Scoring Manual.
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