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

• ClinicalTrials.gov Identifier: NCT03656965
• Recruitment Status: Unknown
• First Posted: September 4, 2018
• Last Update Posted: September 4, 2018
• Sponsor: Kuwait Cancer Control Center
• Information provided by (Responsible Party): Khaled Alsaleh,MD, Kuwait Cancer Control Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Drug Use for Unapproved Schedule	Drug: Acyclovir 800 MG; Combination Product: Radiotherapy and chemotherapy	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Phase III Study in EBV Positive Locally Advanced Nasopharyngeal Carcinoma Treated With Concurrent Chemo-radiotherapy With or Without Anti-Viral Drug
• Actual Study Start Date: May 1, 2018
• Estimated Primary Completion Date: May 2021
• Estimated Study Completion Date: May 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Antiviral Drug with Chemoradiotherapy; Antiviral therapy Acyclovir 800 mg per day during the whole course of treatment.	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.
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; Concurrent chemoradiotherapy which consisted of Cisplatin 40 mg/m2 weekly or 100mg/m2 every 3 weeks with IMRT 70Gy/35 fractions.

Outcome Measures

Primary Outcome Measures :

1. Number of participants with Eliminated EBV titre as assessed by quantitative PCR-DNA in patients with NPC. [ Time Frame: 3 months ]

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Kuwait

Kuwait Cancer Control Center

Kuwait, Kuwait

Sponsors and Collaborators

Kuwait Cancer Control Center

Investigators

• Principal Investigator: Khaled AlSaleh, M.D; Chairman, Radiation Oncology Department

More Information

• Responsible Party: Khaled Alsaleh,MD, Chairman, Radiation Oncology Department, Kuwait Cancer Control Center
• ClinicalTrials.gov Identifier: NCT03656965
• Other Study ID Numbers: RODKCCC
• First Posted: September 4, 2018
• Last Update Posted: September 4, 2018
• Last Verified: August 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Khaled Alsaleh,MD, Kuwait Cancer Control Center:

EBV; Nasopharyngeal Carcinoma

Additional relevant MeSH terms:

Carcinoma; Nasopharyngeal Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Acyclovir; Antiviral Agents; Anti-Infective Agents