The purpose of this study is to determine whether endostar and IMRT is effective in the treatment of locally recurrent nasopharyngeal carcinoma patients compared with IMRT alone.
Locally recurrent nasopharyngeal carcinoma (NPC) may be salvaged by intensity modulated-radiotherapy (IMRT), but severe late toxicities become the most common reason of death in IMRT salvaged NPC patients. The aim of this phase II randomized controlled study is to address the efficacy of concurrent Endostar (Endostatins) with IMRT to reduce the occurrence of severe late toxicities compared with IMRT alone for locally recurrent NPC patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
Endostar (Endostatins) is to give from the first day of IMRT, 201mg, civ d1-14, q3w for two cycles.
IMRT is to give GTV 60Gy in 27 fractions.
First People's Hospital of Foshan
Foshan, Guangdong, China
Cancer Center of Guangzhou Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Clinical Medicine of G.D.P.U.
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Number of participants with grade 4-5 late adverse events as assessed by RTOG/EORTC Late Radiation Morbidity Scoring Schema
Time frame: From 3 months after the end of IMRT to 1 year after the end of IMRT
Number of participants with severe acute toxicities as assessed by CTCAE v3.0
Time frame: From the beginning of IMRT to 3 months after the end of IMRT
Overall survival
Time frame: From the beginning the IMRT to 3 year after the end of IMRT
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Guangzhou, Guangdong, China
The Affiliated GanZhou Hospital of NanChang University
Ganzhou, Jiangxi, China
The First Hospital of Gannan Medical University
Ganzhou, Jiangxi, China
Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
JiangXi Province Tumor Hospital
Nanchang, Jiangxi, China