A Randomized, Phase II Trial Comparing Induction Chemotherapy Gemcitabine Plus Cisplatin With Docetaxel Plus Cisplatin Followed by Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma in Northwest China
Nasopharyngeal carcinoma has an unique geographic distribution, and has different
pathological types, natural history, treatment modalities in endemic and non-endemic
regions. Nasopharyngeal carcinoma is both radiosensitive and chemosensitive.
Chemoradiotherapy is the main therapy choice for the locoregionally advanced nasopharyngeal
carcinoma. However,the optimal chemoradiotherapy regimen has not been determined. Many new
drugs including docetaxel and gemcitabine have been incorporated in the induction
chemotherapy phase of NPC. The investigators designed the present study with induction
chemotherapy follow by CCRT for locoregionally advanced NPC in non-endemic Northwest China,
comparing induction chemotherapy regime of TP and GP. The primary objectives were overall
response rate (ORR), acute toxicity, tolerance; second objective were overall survival (OS),
progression free survival (PFS), rate of distant metastases,late adverse events and quality
of life.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
overall response rate (ORR)
3-year
No
Mei Shi, MD
Principal Investigator
department of radiation oncology
China: Food and Drug Administration
Mshi
NCT01596868
May 2012
May 2015
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