The main objective of this trial was to determine the value of concurrent chemoradiotherapy for Intermediate-risk head and neck squamous cell carcinoma
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
386
Concurrent 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
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Affiliated Hospital of Guilin Medical College
Guilin, Guangxi, China
Hainan General Hospital
Sanya, Hainan, China
Failure-free survival (FFS)
calculated from enrolment to the date of locoregional recurrence,distant metastasis,or death from any cause, whichever occurred first.
Time frame: 3 years
Overall survival (OS)
calculated from enrolment to the date of death from any cause.
Time frame: 3 years
Distant metastasis-free survival(DMFS)
calculated from enrolment to the date of first distant metastasis.
Time frame: 3 years
locoregional recurrence-free survival (LRRFS)
calculated from enrolment to the date of locoregional persistence or 1st locoregional recurrence.
Time frame: 3 years
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.
Time frame: 3 years
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Hunan Cancer Hospital
Changsha, Hunan, China
Xiangya Hospital, Central South University
Changsha, Hunan, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China