Clinical Trials Logo
  1. Home
  2. Epstein-Barr Virus Infection
  3. NCT02135042
  4. Details
NCT02135042 Clinical Trial

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

Epstein-Barr Virus Infection Clinical Trial

Official title:
Randomized Phase II and Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02135042
Other study ID # NRG-HN001
Secondary ID NCI-2014-00635NR
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date April 21, 2014
Est. completion date February 2031

Study information
Verified date October 2023
Source NRG Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

There are two study questions we are asking in this randomized phase II/III trial based on a blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if there is no detectable EBV DNA in their plasma, then patients are randomized to either standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and fluorouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, fluorouracil, gemcitabine hydrochloride, and paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving cisplatin and fluorouracil is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in treating patients with nasopharyngeal cancer.

Description:

Read more »
Other known NCT identifiers
  • NCT02179164
Read more »

Study Design

Related Conditions & MeSH terms

Intervention

Read more »
See more »

Sponsors (2)
Lead Sponsor Collaborator
NRG Oncology National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Australia,  Canada,  China,  Hong Kong,  Puerto Rico,  Singapore,  Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival (OS) (Undetectable Plasma EBV DNA Cohort Phase III) Estimated using the Kaplan-Meier method for each arm. Their distributions will be compared between treatment arms with a 1-sided log rank test. The confidence interval approach will be used for the final analysis of OS. Up to 7 years
Primary Progression-free survival (PFS) (Detectable Plasma EBV DNA Cohort Phase II) Estimated using the Kaplan-Meier method for each arm. Their distributions will be compared between treatment arms with a 1-sided log rank test. A one-sided log rank test will be used to compare the PFS at a significance level of 0.1379. Up to 7 years
Secondary Changes in pure tone audiometry (Phase II and III) Correlation between categorical measures will be summarized by odds ratios, chi-square tests, and associated measures. Adjusted correlation may be derived from analysis of covariance (ANCOVA) models or derived directly using nonparametric analysis of variance (ANOVA) models if normality assumption is violated. Correlations between HHIE-S PRO scores and PTA and FACT-NP hearing, and PTA will be compared as dependent statistics Baseline to up to 1 year
Secondary Changes in QOL (hearing) as assessed by the Hearing Handicap Inventory for the Elderly-Screening version (HHIE-S) (Phase II and III) QOL analysis including overall score and change from baseline will be summarized using mean and standard deviation at each time point for each arm. Overall and nasopharyngeal-specific QOL, hearing QOL (FACT-NP hearing domain, HHIE-S scores), peripheral neuropathy QOL over the short and long term and pure-tone audiometry (PTA) scores will be compared using a two sample independent t test and paired t test if the comparison is within the experimental arm between different time points. Baseline to up to 24 months
Secondary Changes in QOL (peripheral neuropathy) as assessed by the FACT-Taxane (Phase II and III) Baseline to up to 24 months
Secondary Changes in quality of life (QOL) (general and physical well-being) assessed using the Functional Assessment of Cancer Therapy (FACT)-Nasopharyngeal (NP) (Phase II and III) Changes in patient reported outcome (PRO) scores will be correlated to clearance or non-clearance of EBV titers. Descriptive statistics derived from FACT-NP will be used to enrich the understanding of QOL as it pertains to the 2 phase III arms of observation versus additional adjuvant chemotherapy. Univariable and multivariable analysis will be performed using the Cox proportional hazards model for OS and distant metastasis. Pearson correlation will be estimated between general and physical well-being. QOL measures and change from baseline will be correlated to EBV DNA. Baseline to up to 24 months
Secondary Cost effectiveness as assessed by the health-related QOL (HRQOL) from the EuroQol (EQ-5D) instrument (Phase II and III) Incremental cost effectiveness ratios will be compared to determine the probability of cost effectiveness of various interventions, with sensitivity analyses to identify model weaknesses. The expected value of perfect information will be determined to delimit the upper boundary for cost-effective future investment in this area of research. Up to 24 months
Secondary Incidence of acute grade 3-5 adverse events (Phase II and III) Rates of specific acute toxicity profiles and late toxicity profiles will be estimated using a binomial distribution along with their associated 95% confidence intervals and will be compared using Fisher's exact test between the 2 treatment arms. Up to 7 years
Secondary Incidence of death (Phase II and III) Up to 30 days of end of protocol treatment
Secondary Incidence of late grade 3-5 adverse events (Phase II and III) Rates of specific acute toxicity profiles and late toxicity profiles will be estimated using a binomial distribution along with their associated 95% confidence intervals and will be compared using Fisher's exact test between the 2 treatment arms. Up to 7 years
Secondary OS (Detectable Plasma EBV DNA Cohort Phase II) Estimated using the Kaplan-Meier method for each arm. Their distributions will be compared between treatment arms with a 1-sided log rank test. Up to 7 years
Secondary PFS (Undetectable Plasma EBV DNA Cohort Phase III) Estimated using the Kaplan-Meier method for each arm. Their distributions will be compared between treatment arms with a 1-sided log rank test. Up to 7 years
Secondary Time to distant metastasis (DM) (Phase II and III) The cumulative incidence method will be used to estimate local, regional, and distant failure rates. The failure rates for the experimental treatment will be compared against the control using a failure-specific log-rank test. Multivariate analysis will be performed using the Cox proportional hazards model. Up to 7 years
Secondary Time to local progression (Phase II and III) The cumulative incidence method will be used to estimate local, regional, and distant failure rates. The failure rates for the experimental treatment will be compared against the control using a failure-specific log-rank test. Multivariate analysis will be performed using the Cox proportional hazards model. Up to 7 years
Secondary Time to regional progression (Phase II and III) Defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. The cumulative incidence method will be used to estimate local, regional, and distant failure rates. The failure rates for the experimental treatment will be compared against the control using a failure-specific log-rank test. Multivariate analysis will be performed using the Cox proportional hazards model. Up to 7 years
See also
  Status Clinical Trial Phase
Recruiting NCT05683834 - Trial Evaluating the Immunogenicity and Safety of an Adjuvanted Epstein-Barr Virus (EBV) Glycoprotein 350 Vaccine in EBV-seronegative Persons Phase 1/Phase 2
Completed NCT02499302 - Mental Training for CFS Following EBV Infection in Adolescents N/A
Terminated NCT01805037 - Brentuximab Vedotin + Rituximab as Frontline Therapy for Pts w/ CD30+ and/or EBV+ Lymphomas Phase 1/Phase 2
Active, not recruiting NCT04645147 - Safety and Immunogenicity of an Epstein-Barr Virus (EBV) gp350-Ferritin Nanoparticle Vaccine in Healthy Adults With or Without EBV Infection Phase 1
Active, not recruiting NCT05164094 - A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 12- to 30-Year-Old Healthy Adolescents and Adults Phase 1
Active, not recruiting NCT05831111 - A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1195, in 18- to 55-Year-Old Healthy Adults Phase 1