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Individualized Treatment in Treating Patients With Stage II-IVB Nasopharyngeal Cancer Based on EBV DNA

Conditions

Lip, Oral Cavity and Pharynx

Phase II

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.
  • Trial with
    NRG Oncology
  • Start Date
    06/22/2015
  • End Date
    07/30/2021
Trial Image

For more information about this study, contact:

Alexandra Minnella

I'm interested in volunteering

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 877.978.8343

  • Last Updated
    04/25/2019
  • Study HIC
    #1412015097