NCT03656965

EBV Positive Nasopharyngeal Carcinoma Treated With Concurrent Chemo-radiotherapy With or Without Anti-Viral Drug

Randomized Phase III Study in EBV Positive Locally Advanced Nasopharyngeal Carcinoma Treated With Concurrent Chemo-radiotherapy With or Without Anti-Viral Drug

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Kuwait Cancer Control Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

PCR-DNA of EBV test is a good prognostic indicator for survival after treatment (report: Prognostic Impact of Plasma, Epstein-Barr Virus DNA in Patients with Nasopharyngeal Carcinoma Treated using Intensity-Modulated Radiation Therapy. The chances of the local recurrence or metastasis are higher in the patients at same stage with positive PCR-DNA of EBV in Nasopharyngeal carcinoma after same treatment.(ref.) Antiviral drugs have been used to inhibit EBV replication and target viral DNA polymerase are Foscarnet and phosphonoacetic acid both interact directly with the pyrophosphate-binding site of the enzyme, where Acyclovir as antiviral drug act at two levels: as competitive alternative substrates, competing with GTP on the substrate-binding site, and as DNA chain terminators, by incorporating into the growing DNA chain and blocking its elongation due to their acyclic structure.

Conditions

• Drug Use for Unapproved Schedule

Interventions

Type	Name	Description
DRUG	Acyclovir 800 MG	Acyclovir tablets 800 mg per day during the whole course of treatment Or Placebo.
COMBINATION_PRODUCT	Radiotherapy and chemotherapy	Concurrent chemoradiotherapy which consisted of Cisplatin 40 mg/m2 weekly or 100mg/m2 every 3 weeks with IMRT 70Gy/35 fractions.

Timeline

• Start date: 2018-05-01
• Primary completion: 2021-05-01
• Completion: 2021-05-01
• First posted: 2018-09-04
• Last updated: 2018-09-04

Locations

1 site across 1 country: Kuwait