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To determine whether omitting adjuvant CDDP and 5-FU will result in non-inferior overall survival as compared to those patients receiving adjuvant CDDP and 5-FU chemotherapy. OUTLINE: During IMRT, patients receive low-dose cisplatin intravenously for 6. 5 weeks every week and receive low-dose cisplatin intravenously over 30-60 minutes once a week. PHASE II: Patients with detectable EBV DNA from pre-treatment testing are assigned to 1 of two treatment arms. Patients are given a PF regimen consisting of cisplatin IV over 60-120 minutes and fluorouracil IV over 96 hours per week, beginning at least four weeks after IMRT's completion. Patients are treated by a GT programme comprising paclitaxel IV over 1 hour and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 at least four weeks after completion of IMRT. PHASE III: Patients with undetectable EBV DNA from pre-treatment samples are randomized to one of two treatment arms.
Source link: https://clinicaltrials.gov/ct2/show/NCT02135042
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