Phase II Trial of Docetaxel-Cisplatin Neoadjuvant Chemotherapy Followed by Concurrent Radiotherapy With Cetuximab or Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma
Although concurrent chemoradiation is the standard treatment modality for locally advanced
nasopharyngeal carcinoma (NPC), high incidences of distant metastases and severe treatment
related toxicities have become an obstacle to be overcome. A phase Ⅱ study conducted by Hui
et al. showed that neoadjuvant docetaxel-cisplatin (TP) chemotherapy followed by concurrent
chemoradiotherapy was superior to the standard concomitant chemoradiation in terms of the
3-year OS without significantly exacerbating the acute toxicities. Moreover, Bonner et al.
demonstrated that RT with concurrent Cetuximab significantly improved the 5-year OS and did
not increase the treatment induced toxicities when compared with RT alone. Therefore, we
initiated this study to compare the efficacy and toxicity of the two regimens, neoadjuvant
chemotherapy followed by concurrent radiotherapy with cetuximab or weekly cisplatin for
locally advanced NPC.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The time from date of randomization until date of first documented disease progression or death from any cause, assessed up to 3 years.
up to 3 years
Guopei Zhu, M.D.
China: Ministry of Health