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

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

• Epstein-Barr Virus Infection
• Stage II Nasopharyngeal Carcinoma
• Stage III Nasopharyngeal Carcinoma
• Stage IVA Nasopharyngeal Carcinoma
• Stage IVB Nasopharyngeal Carcinoma

Interventions

DRUG

Cisplatin

Given IV

OTHER

Clinical Observation

Undergo clinical observation

DRUG

Fluorouracil

Given IV

DRUG

Gemcitabine Hydrochloride

Given IV

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Paclitaxel

Given IV

OTHER

Quality-of-Life Assessment

Ancillary studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• NRG Oncology

  lead OTHER

Principal Investigators

• Nancy Lee · NRG Oncology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-04-21

Primary Completion

2027-02-28

Completion

2031-02-28

Countries

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

Study Locations