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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

All patients will first undergo standard concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if there is no detectable Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) in their plasma, then patients are randomized to either standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there are 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.

Key Eligibility: 
  • Stage II-IVB cancer of the nasopharynx, with no evidence of distant metastasis 
  • Must have detectable plasma EBV DNA 
  • No prior systemic chemotherapy for the study cancer 
  • No prior radiation that would result in the overlap of therapy fields 
  • Detailed eligibility reviewed when you contact the study team

Study contact by location

Brooklyn

Contact(s)

Lina Flores, RN
(718) 965-9859
lif9061@nyp.org

Primary Investigator(s)

Krishnamurthi Sundaram, MD  (BRK)

Protocol ID(s)

ClinicalTrials.gov:

NCT02135042

Status

Open to Enrollment

Age Group

Adult

Sponsor