Multicenter Phase III Study of Intensity-modulated Radiotherapy Alone Compared to Intensity-modulated Radiotherapy Combined Chemotherapy for Lower 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
- 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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Li Gao, MD
Cancer Hospital, Chinese Academy of Medical Sciences
China: Food and Drug Administration