Nasopharyngeal Cancers Clinical Trial
Official title:
A Randomized, Multicenter, Phase III Trial Comparing Induction CT With Docetaxel, Cisplatin and 5-FU (TPF) Followed by Concurrent CT-RT to Concurrent CT Alone, in Nasopharyngeal Cancers Staged as T2b, T3, T4 and/or With Lymph Node Involvement (>N1)
This is a randomized, multicenter, phase III trial comparing induction chemotherapy with Docetaxel, Cisplatin and 5-Fluorouracil (TPF) followed by concurrent chemoradiotherapy to concurrent chemoradiotherapy alone, in nasopharyngeal cancers staged as T2b, T3, T4 and/or with lymph node involvement (≥ N1. The main end point is the event free survival.
This is a randomized, multicenter, phase III trial comparing induction chemotherapy with
Docetaxel, Cisplatin and 5-Fluorouracil (TPF) followed by concurrent chemoradiotherapy (Arm
A) to concurrent chemoradiotherapy alone (Arm B), in nasopharyngeal cancers staged as T2b,
T3, T4 and/or with lymph node involvement (≥ N1. The main end point is the event free
survival.
The treatments are :
Arm A:
induction chemotherapy: Docetaxel (75 mg/m² administered on D1 of each course, every 3 weeks
via one-hour IV infusion) + Cisplatin(75 mg/m² administered on D1 via one-hour infusion )+
5-FU (750 mg/m²/d administered as a continuous infusion from D1 to D5. The cycles will be
repeated every 3 weeks up to a total of 3 courses.
followed by chemoradiotherapy with Cisplatin (40 mg/m2 starting on D1 of the radiation
therapy) during 7 weeks
Arm B: Chemoradiotherapy with Cisplatin alone (40 mg/m2 starting on D1 of the radiation
therapy) during 7 weeks
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