What is the purpose of this trial?
Primary Objectives for Randomized Phase II and Phase III Studies
- Detectable Plasma EBV DNA Cohort (randomized phase II): The primary objective is to determine whether substituting adjuvant CDDP and 5-FU with gemcitabine and paclitaxel will result in superior progression-free survival.
- Undetectable Plasma EBV DNA Cohort (phase III): The primary objective is to determine whether omitting adjuvant CDDP and 5-FU (observation alone in the adjuvant setting) will result in noninferior overall survival as compared with those patients receiving adjuvant CDDP and 5-FU chemotherapy
Secondary Objectives for Randomized Phase II and Phase III Studies
- To compare the following between arms: Time to distant metastasis; Time to local progression; Time to regional progression; Progression-free survival (Undetectable Cohort); Overall survival (Detectable Cohort) Acute and late toxicity profiles based on clinician-reported CTCAE, v. 4; Death during or within 30 days of end of protocol treatment; Quality of life (general and physical well-being); Quality of life (hearing); Quality of life (peripheral neuropathy); Cost effectiveness.
Ages: 18 years and older
Start Date: 06/23/2015
End Date: 07/31/2021
Last Updated: 04/25/2019
Study HIC#: 1412015097