A Randomized, Multicenter Phase III Clinical Trial Comparing Gemcitabine and Cisplatin With 5-Fluorouracil and Cisplatin in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)
Nasopharyngeal carcinoma (NPC) is most commonly seen in Southeast Asia, especially in
southern and southeastern China ,where the incidence rate has been documented between 10 and
150 cases per 100,000 population per year. NPC is a radiosensitive tumor, and radiotherapy
is considered to be the treatment of choice for most cases. The 5-year survival rate (all
stages) is around 50% .In other words, more than half of the NPC cases will eventually fail
radiotherapy and reasons of the failure are both local relapse and remote metastasis.
For these advanced or metastatic NPC, chemotherapy is the most important therapeutics,and
they are relatively responsive to chemotherapy compared to other head and neck cancers. The
backbone of the treatment for recurrent/metastatic (R/M) NPC is cisplatin containing
regimen, which is also regarded as the standard regimen for other squamous cell carcinoma of
head and neck (SCCHN). The FP regimen is widely used in R/M NPC patients now and its
response rate is around 40%-65%,but the response period is usually short and the adverse
reaction is frequent and badly tolerant, which influent the treatment compliance seriously.
What's more, the catheters and pumps are necessary for continuous infusion of
5-Fluorouracil, which add to the cost, immobility and inconvenience of the treatment.
Preclinical and clinical data show synergistic activity between gemcitabine and cisplatin
without overlapping toxicity. Several clinical trials enrolling a minority of advanced NPC
patients suggest GP regimen has promising effectiveness and well tolerated side effects, and
they indicated a potential possibility that the GP regimen comes to the standard first line
choice instead of the FP regimen
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival (PFS)
36 months
No
li zhang, doctor
Principal Investigator
Sun Yat-sen University
China: Food and Drug Administration
GEM20110714
NCT01528618
January 2012
December 2014
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