The study is to evaluate the efficacy and safety of apatinib for adjuvant treatment of High-risk metastasis of nasopharyngeal carcinoma after IMRT with concurrent chemotherapy,including progression-free survival (PFS),evaluation of drug safety.,and overall survival (OS),distant metastasisfree survival (DMFS),locoregional relapse-free survival (LRRFS),and quality of life score (QoL).
PRIMARY OBJECTIVES: Ⅰ.To determine if adjuvant apatinib after IMRT with concurrent chemotherapy is better to only obeservation after IMRT with concurrent chemotherapy for progression-free survival in High-risk metastasis of nasopharyngeal carcinoma. SECONDARY OBJECTIVES: Ⅰ.To explore the adjuvant medication regimen of local advanced nasopharyngeal carcinoma after IMRT with concurrent chemotherapy. Ⅱ.Provide high-level evidence-based medical evidence for the new individualized treatment strategy of nasopharyngeal carcinoma patients. OUTLINE: Patients are randomized to one of the two treatment arms. ARM 1: treat with apatinib(the dose was 250 mg,orally,qd,28 days for an observation period,Six cycles) for adjuvant treatment of local advanced nasopharyngeal carcinoma after IMRT with concurrent chemotherapy. ARM 2:only obeservation after IMRT with concurrent chemotherapy. IMRT: GTVnx 69.69Gy, GTVnd 60-68Gy, PTV1 59.4Gy and PTV2 54Gy in 33 fractions, 5 days/week. Concurrent chemotherapy:Cisplatin 80mg/m2(D1-3), 3-week chemotherapy for 3 cycles. After completion of study therapy, patients are followed up every 3-4 months for 2 years, then every 6 months for 3 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
Adjuvant treatment by apatinib mesylate tablet to local advanced nasopharyngeal carcinoma after IMRT with concurrent chemotherapy.the dose of apatinib mesylate tablet was 250 mg,orally,qd,28 days for an observation period,six cycles.
Intensity-modulated radiation therapy (IMRT):GTVnx 69.69Gy, GTVnd 60-68Gy, PTV1 59.4Gy and PTV2 54Gy in 33 fractions, 5 days/week.
Concurrent chemotherapy: patients received intravenous cisplatin 80mg/m2(D1-3), 3-week chemotherapy for 3 cycles.
People's Hospital of Baise
Baise City, Guangxi, China
ENROLLING_BY_INVITATIONGuangxi Naxishan Hospital
Guilin, Guangxi, China
ENROLLING_BY_INVITATIONGuilin Medical University
Guilin, Guangxi, China
RECRUITINGProgression-free survival
The time from the first day of therapy to locoregional relapse, distant relapse or tumor-related death
Time frame: 3 years
Overall survival
The time from the first day of therapy to death or last follow-up
Time frame: 3 years
Locoregional relapse-free survival
The time from the first day of treatment to the time of first locoregional relapse
Time frame: 3 years
Distant metastasis-free survival
The time from the first day of treatment to the time of first distant metastasis
Time frame: 3 years
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People's Hospital of Laibin
Laibin, Guangxi, China
ENROLLING_BY_INVITATIONPeople's Hospital of Lingshan
Linshan, Guangxi, China
ENROLLING_BY_INVITATIONWuzhou Red Cross Hospital
Wuzhou, Guangxi, China
ENROLLING_BY_INVITATION