Nasopharyngeal Carcinoma Clinical Trial
Official title:
A Multicenter, Phase II Clinical Study of Adjuvant Apatinib After IMRT With Concurrent Chemotherapy Versus IMRT With Concurrent Chemotherapy in High-risk Metastasis of Nasopharyngeal Carcinoma
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.
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