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

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Phase III Study in EBV Positive Locally Advanced Nasopharyngeal Carcinoma Treated With Concurrent Chemo-radiotherapy With or Without Anti-Viral Drug

Conditions
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Drug Use for Unapproved Schedule

Intervention / Treatment
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* Drug: Acyclovir 800 MG
* Combination Product: Radiotherapy and chemotherapy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antiviral Drug with Chemoradiotherapy<br>Antiviral therapy Acyclovir 800 mg per day during the whole course of treatment. | Drug: Acyclovir 800 MG<br>* Acyclovir tablets 800 mg per day during the whole course of treatment Or Placebo.<br>Combination Product: Radiotherapy and chemotherapy<br>* Concurrent chemoradiotherapy which consisted of Cisplatin 40 mg/m2 weekly or 100mg/m2 every 3 weeks with IMRT 70Gy/35 fractions.<br>|
| Other: Chemoradiotherapy<br>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<br>* Concurrent chemoradiotherapy which consisted of Cisplatin 40 mg/m2 weekly or 100mg/m2 every 3 weeks with IMRT 70Gy/35 fractions.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EBV, Nasopharyngeal Carcinoma