Clinical trial NCT03656965: EBV Positive Nasopharyngeal Carcinoma Treated With Concurrent Chemo-radiotherapy With or Without Anti-Viral Drug
Official title: Randomized Phase III Study in EBV Positive Locally Advanced Nasopharyngeal Carcinoma Treated With Concurrent Chemo-radiotherapy With or Without Anti-Viral Drug
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Drug Use for Unapproved Schedule
Keywords: EBV
Nasopharyngeal Carcinoma
Lead sponsor: Kuwait Cancer Control Center
Sponsor class: OTHER
First posted: 2018-09-04
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of participants with Eliminated EBV titre as assessed by quantitative PCR-DNA in patients with NPC.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kuwait
country: Kuwait
facility: Kuwait Cancer Control Center
Study officials:
affiliation: Chairman, Radiation Oncology Department
name: Khaled AlSaleh, M.D
role: PRINCIPAL_INVESTIGATOR
References: