Individualized Treatment in Treating Patients With Stage II-IVB Nasopharyngeal Cancer Based on EBV DNA
Lip, Oral Cavity and Pharynx
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.
- Ages18 years and older
- Trial withNRG Oncology Foundation, Inc.
- Start Date06/22/2015
- End Date07/30/2021
- Last Updated08/24/2020
- Study HIC#1412015097