The purpose of this study is to verify that simultaneous integrated boost IMRT (SIB-IMRT) alone is non-inferior to SIB-IMRT combined with concurrent chemotherapy for low-risk locally advanced nasopharyngeal carcinoma.
* There were several randomized clinical trials confirmed that concurrent chemoradiotherapy (CCRT) is superior to radiotherapy (RT)alone for locally advanced NPC, most of the patients in the trials were treated with conventional radiotherapy technique. * As the new technique of IMRT used more and more in the clinical practice, the role of concurrent chemoradiotherapy (CCRT) seems blurred, in two of Hongkong phaseIII studies(NPC9901/9902), half of the patients were treated by 3-dimensional conformal radiotherapy (3DCRT)/IMRT,the results showed that there were no significant different in terms of overall survival between RT alone and CCRT groups. Furthermore, several large sample size retrospective studies from China, showed that there were no advantage of CCRT over RT alone when treated by SIB-IMRT. * In an analysis of who will benefit from CCRT,( Lin, et.al, IJROBP,2004; 60:156-164), the author divided the locally advanced NPC patients into two groups, with the high-risk group defined as patients met at least one of following criteria: nodal size \>6 cm, (2) supraclavicular node metastasesN3, T4N2 and multiple neck node metastases with 1 node \>4cm. * Based on these information, we hypothesize that, for low-risk locally advanced NPC patients, there may no need CCRT under SIB-IMRT treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
590
SIB-IMRT was given to the patients with regimen of 69.96Gy-73.92Gy to the gross target volume, 60Gy to the high risk clinical target volume, 50Gy to the low risk clinical target volume
Cisplatin 100mg/m2 was delivered at d1,d22 and d43 to the CCRT group patients during radiotherapy.
Department of nasopharyngeal carcinoma, Cancer hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGDepartment of Radiation oncology, Cancer hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
RECRUITINGZhongnan Hospital of Wuhan University
Wuhan, Hubei, China
overall survival
according to the recruitment, a interrim analysis will done in July, 2019, if there is inferior finding of RT alone group, the study will premature terminate
Time frame: 5 years
Acute and late toxicities
* compare the acute radiation and chemotherapy-related toxicities during treatment course * compare late toxicities after treatment
Time frame: 5years
3 year Progression-free survival (PFS)
to compare the 3years PFS between the IMRT alone and IMRT with concurrent chemoradiotherapy
Time frame: 5year
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Tongji hospital, Huazhong University of Science & Technology
Wuhan, Hubei, China
RECRUITINGJiangxi province cancer hospital
Nanchang, Jiangxi, China
NOT_YET_RECRUITINGCancer hospital, Chinese Academy of Medical Sciences
Beijing, China
RECRUITING