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

Primary Purpose

Drug Use for Unapproved Schedule

Status
Unknown status
Phase
Phase 3
Locations
Kuwait
Study Type
Interventional
Intervention
Acyclovir 800 MG
Radiotherapy and chemotherapy
Sponsored by
Kuwait Cancer Control Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug Use for Unapproved Schedule focused on measuring EBV, Nasopharyngeal Carcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kuwait Cancer Control Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Antiviral Drug with Chemoradiotherapy

Chemoradiotherapy

Arm Description

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

Patients will receive concurrent chemoradiotherapy which consisted of Cisplatin 40 mg/m2 weekly or 100mg/m2 every 3 weeks with IMRT 70Gy/35 fractions.

Outcomes

Primary Outcome Measures

Number of participants with Eliminated EBV titre as assessed by quantitative PCR-DNA in patients with NPC.

Secondary Outcome Measures

Full Information

First Posted
August 26, 2018
Last Updated
August 30, 2018
Sponsor
Kuwait Cancer Control Center
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1. Study Identification

Unique Protocol Identification Number
NCT03656965
Brief Title
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

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
May 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuwait Cancer Control Center

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Use for Unapproved Schedule
Keywords
EBV, Nasopharyngeal Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Antiviral Drug with Chemoradiotherapy
Arm Type
Experimental
Arm Description
Antiviral therapy Acyclovir 800 mg per day during the whole course of treatment.
Arm Title
Chemoradiotherapy
Arm Type
Other
Arm Description
Patients will receive concurrent chemoradiotherapy which consisted of Cisplatin 40 mg/m2 weekly or 100mg/m2 every 3 weeks with IMRT 70Gy/35 fractions.
Intervention Type
Drug
Intervention Name(s)
Acyclovir 800 MG
Intervention Description
Acyclovir tablets 800 mg per day during the whole course of treatment Or Placebo.
Intervention Type
Combination Product
Intervention Name(s)
Radiotherapy and chemotherapy
Intervention Description
Concurrent chemoradiotherapy which consisted of Cisplatin 40 mg/m2 weekly or 100mg/m2 every 3 weeks with IMRT 70Gy/35 fractions.
Primary Outcome Measure Information:
Title
Number of participants with Eliminated EBV titre as assessed by quantitative PCR-DNA in patients with NPC.
Time Frame
3 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khaled AlSaleh, M.D
Organizational Affiliation
Chairman, Radiation Oncology Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kuwait Cancer Control Center
City
Kuwait
Country
Kuwait

12. IPD Sharing Statement

Learn more about this trial

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

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