Randomized Trial to Evaluate Therapeutic Gain by Changing Chemoradiotherapy From Concurrent-adjuvant to Induction-concurrent Sequence, and Radiotherapy From Conventional to Accelerated Fractionation for Advanced Nasopharyngeal Carcinoma
1. primary objectives include
1. comparing induction chemotherapy with Cisplatin + 5-Fluorouracil versus adjuvant
chemotherapy with Cisplatin + 5-Fluorouracil(PF-Pvs P-PF)
2. comparing induction chemotherapy with Cisplatin + Capecitabine versus adjuvant
chemotherapy with Cisplatin + 5-Fluorouracil(PX-P vs P-PF)
3. comparing accelerated fractionation versus conventional fractionation (AF vs
CF)radiotherapy.
2. secondary objectives include
1. comparing induction chemotherapy with Cisplatin + Capecitabine versus induction
chemotherapy with Cisplatin + 5-Fluorouracil(PX-P vs PX-P)
2. Comparing concurrent-adjuvant (CA) versus induction-concurrent (IC) chemotherapy
sequence.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-Free Survival, defined as the time to treatment failure at any site or death due to any cause, at 5-year.
5 years
Yes
Anne W.M. Lee, F.R.C.R.
Principal Investigator
Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital, Hong Kong
Hong Kong: Ethics Committee
NPC-0501 Trial
NCT00379262
September 2006
April 2017
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