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

NCT03656965 | Unknown Phase 3

• 1 other identifier: RODKCCC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

EBV; Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Number of participants with Eliminated EBV titre as assessed by quantitative PCR-DNA in patients with NPC.

  3 months

Study Arms (2)

Antiviral Drug with Chemoradiotherapy

EXPERIMENTAL

Antiviral therapy Acyclovir 800 mg per day during the whole course of treatment.

Drug: Acyclovir 800 MG; Combination Product: Radiotherapy and chemotherapy

Chemoradiotherapy

OTHER

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

Interventions

Acyclovir 800 MG DRUG

Acyclovir tablets 800 mg per day during the whole course of treatment Or Placebo.

Antiviral Drug with Chemoradiotherapy

Radiotherapy and chemotherapy COMBINATION_PRODUCT

Concurrent chemoradiotherapy which consisted of Cisplatin 40 mg/m2 weekly or 100mg/m2 every 3 weeks with IMRT 70Gy/35 fractions.

Antiviral Drug with Chemoradiotherapy; Chemoradiotherapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kuwait Cancer Control Center: lead

Study Sites (1)

Kuwait Cancer Control Center

Kuwait City, Kuwait

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Acyclovir; Radiotherapy; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Khaled AlSaleh, M.D

  Chairman, Radiation Oncology Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Radiation Oncology Department

Study Record Dates

• First Submitted: August 26, 2018
• First Posted: September 4, 2018
• Study Start: May 1, 2018
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: September 4, 2018

Record last verified: 2018-08

Locations

KU (1)