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

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.

Study Overview

• Status: Unknown
• Conditions: Drug Use for Unapproved Schedule
• Intervention / Treatment: Drug: Acyclovir 800 MG; Combination product: Radiotherapy and chemotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• Kuwait
  • Kuwait, Kuwait
    • Kuwait Cancer control center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Antiviral Drug with Chemoradiotherapy; Antiviral therapy Acyclovir 800 mg per day during the whole course of treatment.	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.
Other: Chemoradiotherapy; Patients will receive concurrent chemoradiotherapy which consisted of Cisplatin 40 mg/m2 weekly or 100mg/m2 every 3 weeks with IMRT 70Gy/35 fractions.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with Eliminated EBV titre as assessed by quantitative PCR-DNA in patients with NPC.	3 months

Collaborators and Investigators

• Sponsor: Kuwait Cancer Control Center
• Investigators: Principal Investigator: Khaled AlSaleh, M.D, Chairman, Radiation Oncology Department

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: August 26, 2018
• First Submitted That Met QC Criteria: August 30, 2018
• First Posted (Actual): September 4, 2018

Study Record Updates

• Last Update Posted (Actual): September 4, 2018
• Last Update Submitted That Met QC Criteria: August 30, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: EBV; Nasopharyngeal Carcinoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma; Anti-Infective Agents; Antiviral Agents; Acyclovir
• Other Study ID Numbers: RODKCCC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No