Trial | NCT03656965  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    aciclovir cisplatin ...

  • Study Participants

    50
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 Started
May 01
2018
Primary Completion
May 31
2021
Anticipated
Study Completion
May 31
2021
Anticipated
Last Update
Sep 04
2018

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.

Antiviral Drug with Chemoradiotherapy Experimental

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

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.

Criteria 

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
No Results Posted