Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02135042 · ClinicalTrials.gov registry record · Phase 2
Individualized Treatment in Treating Patients With Stage II-IVB Nasopharyngeal Cancer Based on EBV DNA
A Phase 2 study of Epstein-Barr Virus Infection and Stage II Nasopharyngeal Carcinoma, sponsored by NRG Oncology.
- Active
- Registry status
- Phase 2
- Development phase
- 685
- Enrollment target
- 20
- Study locations
NCT02135042 is a Phase 2 study of Epstein-Barr Virus Infection and Stage II Nasopharyngeal Carcinoma that is active but no longer recruiting, run by NRG Oncology. The registered enrollment target is 685 participants, above the 370-participant average among 6 other Epstein-Barr Virus Infection trials with a reported enrollment target (85% higher). The trial reports 20 study locations across 3 states.
The verdict
NCT02135042, a Phase 2 study of Epstein-Barr Virus Infection and Stage II Nasopharyngeal Carcinoma, is active but no longer recruiting, sponsored by NRG Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 685 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Cisplatin
- DRUG Fluorouracil
- OTHER Clinical Observation
- RADIATION Intensity-Modulated Radiation Therapy
- DRUG Gemcitabine Hydrochloride
Study Locations (20)
California
- Sutter Cancer Centers Radiation Oncology Services-Auburn - Auburn
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Mills-Peninsula Medical Center - Burlingame
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park - Cameron Park
- City of Hope Comprehensive Cancer Center - Duarte
- Kaiser Permanente Dublin - Dublin
- Fresno Cancer Center - Fresno
- UC San Diego Moores Cancer Center - La Jolla
- Memorial Medical Center - Modesto
- Kaiser Permanente Oakland-Broadway - Oakland
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- Palo Alto Medical Foundation Health Care - Palo Alto
- Stanford Cancer Institute Palo Alto - Palo Alto
- Kaiser Permanente-Rancho Cordova Cancer Center - Rancho Cordova
- Rohnert Park Cancer Center - Rohnert Park
- Sutter Cancer Centers Radiation Oncology Services-Roseville - Roseville
- The Permanente Medical Group-Roseville Radiation Oncology - Roseville
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
- The Kirklin Clinic at Acton Road - Birmingham
Arizona
- Banner University Medical Center - Tucson - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 685 participants |
| Start Date | 2014-04-21 |
| Est. Completion | 2031-02 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02135042
The ClinicalTrials.gov registry entry for NCT02135042 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 685 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 370-participant average among 6 other Epstein-Barr Virus Infection trials with a reported enrollment target (85% higher). The listed sponsor is NRG Oncology, which has 64 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Epstein-Barr Virus Infection appearing as the primary indexed condition, and to 5 interventions - of which Cisplatin is the first listed.
NCT02135042 reports 20 study locations spanning 3 distinct geographic areas - top geographies include California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT02135042 about?
NCT02135042 is a clinical study titled "Individualized Treatment in Treating Patients With Stage II-IVB Nasopharyngeal Cancer Based on EBV DNA". 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 ra...
What is the current status of trial NCT02135042?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 685 participants. The study started on 2014-04-21. Estimated completion is 2031-02.
What conditions does trial NCT02135042 study?
This clinical trial studies the following conditions: Epstein-Barr Virus Infection, Stage II Nasopharyngeal Carcinoma, Stage III Nasopharyngeal Carcinoma, Stage IVA Nasopharyngeal Carcinoma, Stage IVB Nasopharyngeal Carcinoma.
What interventions are being tested in trial NCT02135042?
The interventions under investigation include: Cisplatin (DRUG), Fluorouracil (DRUG), Clinical Observation (OTHER), Intensity-Modulated Radiation Therapy (RADIATION), Gemcitabine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT02135042?
This trial is sponsored by NRG Oncology, which has 64 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02135042 being conducted?
This trial has 20 study locations across Alabama, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Epstein-Barr Virus Infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Epstein-Barr Virus (EBV) gH/gL/gp42-Ferritin Nanoparticle Vaccine With or Without gp350-Ferritin in Healthy Adults With or Without EBV Infection
RECRUITING · Phase 1
-
Trial Evaluating the Immunogenicity and Safety of an Adjuvanted Epstein-Barr Virus (EBV) Glycoprotein 350 Vaccine in EBV-seronegative Persons
ACTIVE NOT RECRUITING · Phase 1
-
A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1195, in 18- to 55-Year-Old Healthy Participants
ACTIVE NOT RECRUITING · Phase 1
-
Safety and Immunogenicity of an Epstein-Barr Virus (EBV) gp350-Ferritin Nanoparticle Vaccine in Healthy Adults With or Without EBV Infection
ACTIVE NOT RECRUITING · Phase 1
-
A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 10- to 30-Year-Old Healthy Adolescents and Adults
ACTIVE NOT RECRUITING · Phase 1
-
Administration of Donor T Cells With the Caspase-9 Suicide Gene
ACTIVE NOT RECRUITING · Phase 1
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.