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Status unknownNCT03656965Updated Sep 4, 2018

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

A Phase 3 interventional study of Acyclovir 800 MG and Radiotherapy and chemotherapy in Drug Use for Unapproved Schedule, sponsored by Kuwait Cancer Control Center. Status unknown at 1 site in Kuwait. Per ClinicalTrials.gov, last updated 2018-09-04.

Sponsored by Kuwait Cancer Control Center · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2018), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled May 2018, registered Aug 2018).
Phase
Phase 3
Study type
Interventional
Enrollment
50
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Drug Use for Unapproved Schedule

Keywords

  • EBV
  • Nasopharyngeal Carcinoma
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 50 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Kuwait Cancer Control Center is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Antiviral Drug with Chemoradiotherapy

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

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

  • 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

Interventions

  • DrugAcyclovir 800 MG

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

  • Combination productRadiotherapy and chemotherapy

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

06

What researchers measure

Primary outcomes

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

    Time frame: 3 months

07

Study locations

1 site
  • Kuwait Cancer Control Center
    Kuwait, Kuwait
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03656965
Lead sponsor
Kuwait Cancer Control Center
Responsible party
Khaled Alsaleh,MD (Chairman, Radiation Oncology Department, Kuwait Cancer Control Center) — Principal investigator
First posted
Sep 4, 2018
Start date
May 1, 2018
Primary completion
May 2021 (estimated)
Completion
May 2021 (estimated)
Last update
Sep 4, 2018

Study contacts

Khaled AlSaleh, M.D
principal investigator · Chairman, Radiation Oncology Department

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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