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Trial record 59 of 112 for:    acyclovir

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03656965
Recruitment Status : Active, not recruiting
First Posted : September 3, 2018
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
Khaled Alsaleh,MD, 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.


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

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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

Resource links provided by the National Library of Medicine


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.




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 ]


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03656965


Locations
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Kuwait
Kuwait Cancer Control Center
Kuwait, Kuwait
Sponsors and Collaborators
Kuwait Cancer Control Center
Investigators
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Principal Investigator: Khaled AlSaleh, M.D Chairman, Radiation Oncology Department

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Responsible Party: Khaled Alsaleh,MD, Chairman, Radiation Oncology Department, Kuwait Cancer Control Center
ClinicalTrials.gov Identifier: NCT03656965     History of Changes
Other Study ID Numbers: RODKCCC
First Posted: September 3, 2018    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: August 2018

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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:
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Acyclovir
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
Antiviral Agents
Anti-Infective Agents