The purpose of this study is to investigate whether the addition of metronomic capecitabine to the standard treatment can improve prognosis in locoregionally advanced head and neck squamous cell carcinoma.
The standard treatment for resectable locoregionally advanced squamous cell carcinoma of the head and the neck (LAHNSCC) is a regimen consisting of radical surgery plus radiotherapy or concurrent chemoradiotherapy. And induction chemotherapy plus radical radiotherapy or concurrent chemoradiotherapy is also recommended for locoregionally advanced squamous cell carcinoma of larynx and hypopharynx. With the extensive application of comprehensive treatment, the 5-year overall survival of LAHNSCC has not reached 50% yet. So, it is urgent to explore a regimen with high efficiency and low toxicity on the basis of existing standard treatment. Two retrospective studies found that the metronomic use of orally administered fluorouracil drugs following the reference treatment significantly improved prognosis in LAHNSCC. And capecitabine is one kind of the oral fluorouracil drugs, which has high efficiency and low toxicity. Indeed, metronomic capecitabine maintenance was shown to be effective in patients with breast cancer, colorectal cancer, and nasopharyngeal carcinoma in phase III trials. The abovementioned studies suggested the promising use of metronomic capecitabine in LAHNSCC. However, there has been no randomized trials in this field. Therefore, we initiated a randomized phase III trial to investigate the efficacy and safety of the addition of metronomic capecitabine to the standard treatment in LAHNSCC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
Metronomic capecitabine (650 mg/m2 bid, d1-21, q3w) for 1 year
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGProgression-free survival
PFS will be measured from the day of randomization until treatment failure, death from any cause, or the last follow-up visit, whichever occurred first.
Time frame: 2 years
Overall survival
OS will be measured from the day of randomization until death due to any cause, or the last follow-up visit.
Time frame: 2 years
Distant failure-free survival
DFFS will be measured from the day of randomization until death until distant metastasis, or the last follow-up visit.
Time frame: 2 years
Locoregional failure-free survival
LRFFS will be measured from the day of randomization until death until local and/or regional recurrence, or the last follow-up visit.
Time frame: 2 years
Adverse events
The incidence of capecitabine-related and other adverse events.
Time frame: Up to 2 years
Patient reported quality-of-life score
Patient reported quality of life would be evaluated using the Quality of Life Questionnaire-Core 30 module (QLQ-C30). The score is between 0-100, and the higher score means worse quality of life.
Time frame: Up to 2 years
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