A Randomized Phase III Non-inferiority Study of Concurrent Chemoradiotherapy With Nedaplatin Versus Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma
Nasopharyngeal carcinoma (NPC) is endemic in Southern China and Southeast Asia. Several
prospective randomized trials have demonstrated that concurrent chemoradiotherapy was
superior to radiotherapy alone in the treatment of locoregionally advanced NPC.
Cisplatin-based chemotherapy has been shown to have higher response rates in NPC than
noncisplatin regimens. However, the patients' compliance was unsatisfactory because the
obvious gastrointestinal toxicity of cisplatin. Nedaplatin is the new second generation
platinum and it has slight gastrointestinal reaction. Our trial is in order to study the
effectiveness of nedaplatin or cisplatin with intensity-modulated radiation therapy (IMRT)
chemoradiotherapy in treating patients with locoregionally advanced NPC.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.
HaiQiang Mai, MD,Ph.D
China: Ministry of Health
Sun Yat-sen University