Concurrent cisplatin-based chemotherapy plus radiotherapy increased the risk of treatment-related death and severe acute toxicity. The survival benefit of adding concurrent chemotherapy to intensity modulated radiation in patients with locoregionally advanced nasopharyngeal carcinoma is unclear. Gemcitabine plus cisplatin chemotherapy combine with radiotherapy was effective and well tolerated by patients with locoregionally advanced NPC.
The purpose of this study is to compare gemcitabine plus cisplatin induction chemotherapy combine intensity-modulated radiotherapy with or without concurrent cisplatin in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to reevaluate the value of concurrent cisplatin when 4 cycles induction chemotherapy (gemcitabine+cisplatin) and IMRT is used.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
300
Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30mg/m2,on day 1) repeated every week for 6 cycles during radiotherapy.
Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT.
Cancer Center,Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGState Key Laboratory of Oncology in South China, Cancer Center, Sun Yat-sen University
Guangzhou, China
NOT_YET_RECRUITINGOverall survival
Overall survival is calculated from randomization to death from any cause.
Time frame: 3-year
Failure-free survival
Failure-free survival is calculated from the date of randomization to the date of the first failure at any site.
Time frame: 3-year
Locoregional failure-free survival
the latency to the first local failure
Time frame: 3-year
Distant failure-free survival
The latency to the first remote failure
Time frame: 3-year
Difference in the complete response rates between the two treatment arms
Time frame: 12 weeks after the completion of therapy
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