General Information
Age Group
AdultsStatus
RecruitingProtocol Number
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