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

Phase 3

• Conditions: Drug Use for Unapproved Schedule
• Interventions: Combination Product: Radiotherapy and chemotherapy; Drug: Acyclovir 800 MG

• Registration Number: NCT03656965
• Lead Sponsor: Kuwait Cancer Control Center

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-05-01
• Status Verified: 2018-08
• Study First Submitted: 2018-08-26
• Study First Submitted QC: 2018-08-30
• Last Update Submitted: 2018-08-30
• Study First Posted: 2018-09-04
• Last Update Posted: 2018-09-04
• Primary Completion: 2021-05
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemoradiotherapy	Radiotherapy and chemotherapy	Patients will receive 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	Radiotherapy and chemotherapy	Antiviral therapy Acyclovir 800 mg per day during the whole course of treatment.
Antiviral Drug with Chemoradiotherapy	Acyclovir 800 MG	Antiviral therapy Acyclovir 800 mg per day during the whole course of treatment.

Primary Outcome Measures

Name	Time	Method
Number of participants with Eliminated EBV titre as assessed by quantitative PCR-DNA in patients with NPC.	3 months

Trial Locations

Locations (1)

Kuwait Cancer Control Center; 🇰🇼 Kuwait, Kuwait