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

Drug Use for Unapproved Schedule Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03656965
• Other study ID #: RODKCCC
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: May 1, 2018
• Est. completion date: May 2021

Study information

• Verified date: August 2018
• Source: Kuwait Cancer Control Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Confirmed histopathologic diagnosis of nasopharyngeal squamous cell carcinoma, types WHO II-III.

• Stage II-IVB

• Requiring primary concomitant Radiotherapy and Chemotherapy.

• No head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies.

• Positive PCR-DNA EBV

• = 18 years of age

• ECOG performance status 0-1

• WBC = 4,000/µl, platelets = 100,000/µl; serum creatinine = 1.6 mg/dl or 24 hr. calculated creatinine clearance = 60 ml/min (see Section 3.1.6).

• Pre-treatment evaluation of tumor extent and tumor measurement.

• Nutritional and general physical condition must be considered compatible with the proposed radio-therapeutic treatment.

• Signed study-specific consent form prior to study entry Assessment.

Exclusion Criteria:

• Prior radiotherapy to the head and neck or any prior chemotherapy = 6 months prior to study entry.

• Other malignancy except non-melanoma skin cancer or a carcinoma not of head and neck origin = 5 years

• Evidence of distant metastasis.

• on any experimental therapeutic cancer treatment.

• major medical or psychiatric illness.

• pregnant females.

• Age = 18 years old

Related Conditions & MeSH terms

• Carcinoma
• Drug Use for Unapproved Schedule
• Nasopharyngeal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Kuwait	Kuwait Cancer Control Center	Kuwait

Sponsors (1)

Lead Sponsor	Collaborator
Kuwait Cancer Control Center

Country where clinical trial is conducted

Kuwait, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Eliminated EBV titre as assessed by quantitative PCR-DNA in patients with NPC.		3 months