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Individualized Treatment in Treating Patients With Stage II-IVB Nasopharyngeal Cancer Based on EBV DNA
NCT02135042 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 685 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NRG Oncology, which has 162 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02135042 reports 20 study locations spanning 3 distinct geographic areas — top geographies include California, Alabama, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02135042?
This trial is sponsored by NRG Oncology, which has 162 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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