A Randomized Multicenter Phase II Study of Intensity-modulated Radiotherapy Combined With Chemotherapy Versus Intensity-modulated Radiotherapy Alone for Stage II Nasopharyngeal Carcinoma
Clinical Stage II nasopharyngeal carcinoma consisted of T2N0M0, T1N1M0, T2N1M0 three
subgroups, the data came from conventional radiotherapy era showed that the prognosis of
this three subgroups were different, the N1 groups suffered more distant metastasis than N0
group, and some literature showed that combined chemotherapy with radiotherapy in stage II
patients can improve the treatment results.
Intensity-modulated radiotherapy (IMRT)now is an widely used technique in the treatment of
nasopharyngeal carcinoma, the preliminary results showed that IMRT can improve the quality
of life in nasopharyngeal through salivary gland preservation.
Compared IMRT alone with IMRT plus cisplatin concurrent chemotherapy in the treatment of
stageII nasopharyngeal carcinoma, we hope to confirm whether stage II (and which subgroup)
nasopharyngeal carcinoma will be benefit from concurrent chemoradiotherapy.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Acute toxicity will be measured by CTCAE3.0
Li Gao, MD
Cancer Hospital, Chinese Academy of Medical Sciences
China: Ministry of Health