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

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.

Participation Guidelines

Ages: 18 years and older

Gender: Both

NRG Oncology

Start Date: 06/23/2015

End Date: 07/31/2021

Last Updated: 04/25/2019

Study HIC#: 1412015097

Get Involved

For more information about this study, contact:
Elzbieta Nowacki
+1 203-737-7981

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email or call 1-877-978-8348.

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