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NRG HN001

Status:

Recruiting | Phase II and III

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)

Study Purpose:

To compare the standard treatment for nasopharyngeal cancer with the drug combination gemcitabine and paclitaxel to see if patients do better and live longer.  This is also testing if directing treatment using a blood test to look for the Epstien Bar Virus will result in patients doing better and not needing as much treatment.

Interventions:   

All patients will initially be treated with the standard of care chemotherapy and radiation therapy at the same time.  After that is complete patients will have their blood drawn and be assigned to the treatment groups based on the presence of the Epstein Barr Virus in their blood.             

For patients who have the Epstein Barr Virus in their blood

  • Arm 1: Cisplatin and Fluorouracil every 28 days for 3 cycles
  • Arm 2: Gemcitabine and Paclitaxel on day 1 and day 8 of each 21 day cycle for 4 cycles.

For patients who do not have the Epstein Barr Virus in their blood

  • Arm 3: Cisplatin and Fluorouracil every 28 days for 3 cycles
  • Arm 4: Observation

Key Participation Requirements:

Gender:

Male or Female

Age:

19 or older

Diagnosis:

Nasopharyngeal Cancer

Eligibility:

Must have detectable Epstein Barr Virus in their blood before starting the standard chemotherapy with radiation treatment.

No significant hearing lose that requires a hearing aid or other treatment to aid in hearing.

No significant problems with neuropathy (loss of feeling in hands and/or feet).

No evidence of distant metastatic cancer.

No Prior therapy.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Methodist Health System Trial Code:

NRG HN001

For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today!