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

Last updated: August 30, 2018
Sponsor: Kuwait Cancer Control Center
Overall Status: Active - Not Recruiting

Phase

3

Condition

Carcinoma

Treatment

N/A

Clinical Study ID

NCT03656965
RODKCCC
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Confirmed histopathologic diagnosis of nasopharyngeal squamous cell carcinoma, typesWHO 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 orexcisional 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 theproposed radio-therapeutic treatment.

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

Exclusion

Exclusion Criteria:

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

  • Other malignancy except non-melanoma skin cancer or a carcinoma not of head and neckorigin ≤ 5 years

  • Evidence of distant metastasis.

  • on any experimental therapeutic cancer treatment.

  • major medical or psychiatric illness.

  • pregnant females.

  • Age ≤ 18 years old

Study Design

Total Participants: 50
Study Start date:
May 01, 2018
Estimated Completion Date:
May 31, 2021

Connect with a study center

  • Kuwait Cancer Control Center

    Kuwait,
    Kuwait

    Site Not Available

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