This is an randomized, controlled, multicenter phase 3 clinical trial. The purpose of this study is to evaluate the efficacy and safety of single-agent capecitabine as adjuvant chemotherapy in locoregionally advanced nasopharyngeal carcinoma (NPC).
In this study, NPC patients (stage III-IV A, except T3-4 N0 and T3 N1) who finished the curative radiotherapy will be randomized to the observation group and capecitabine group (650 mg/m2 bid, p.o.,d1-21,q3wks; continued until disease progression, unacceptable toxicity, or over 1 year). The primary endpoint is progression-free survival (PFS). Secondary end points include overall survival (OS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS), toxic effects, and quality of life (QOL). All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
406
Patients will receive capecitabine (650 mg/m2 bid, p.o.,d1-21,q3wks; continued until disease progression, unacceptable toxicity, or over 1 year).
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Progression-free survival
Time frame: 3 years
Overall survival
Time frame: 3 years
Distant failure-free survival
Time frame: 3 years
Locoregional failure-free survival
Time frame: 3 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 1 year
Quality of life (QOL) as assessed by EORTC quality of life questionnaire(QLQ)-C30
Time frame: 1 year
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