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8110 Gatehouse Road, Falls Church, VA 22042

NRG-HN001, Randomized Phase II and Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA)

General Information

Age Group

Adult

Status

Recruiting

Protocol Number

NCT02135042

Background Information

This study was designed to help determine whether substituting adjuvant concurrent high dose cisplatin (CDDP) and fluorouracil (5-FU) with gemcitabine (gemcitabine hydrochloride) and paclitaxel will result in superior progression-free survival. This study may also help determine whether omitting adjuvant CDDP and 5-FU (observation alone in the adjuvant setting) will result in non-inferior overall survival as compared with those patients receiving adjuvant CDDP and 5-FU chemotherapy. (Undetectable Plasma EBV DNA Cohort Phase III)
 

Offered At

Inova Fairfax Hospital
3300 Gallows Road
Fairfax, VA 22031

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031

A department of Inova Fairfax Hospital

Eligibility Information

  • Biopsy proven (from primary lesion and/or lymph nodes) diagnosis of cancer of the nasopharynx
  • Additional eligibility in protocol

Ineligibility Information

  • Prior invasive malignancy (except node negative, non-melanomatous skin cancer) unless disease free for a minimum of 1095 days [3 years] (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
  • Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; however, at least 6-weeks recovery is necessary if the last regimen included nitrosourea or mitomycin.
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
  • Patients with hearing loss assessed to be primarily sensorineural in nature, requiring a hearing aid, or intervention (i.e. interfering in a clinically significant way with activities of daily living); a conductive hearing loss that is tumor-related is allowed;
  • Greater than grade 2 peripheral sensory neuropathy (CTCAE, v. 4.0)
  • Additional exclusions in protocol

For more information go to: https://clinicaltrials.gov/ct2/show/NCT02135042