Drug Use for Unapproved SchedulePhase 3NCT03656965
EBV Positive Nasopharyngeal Carcinoma Treated With Concurrent Chemo-radiotherapy With or Without Anti-Viral Drug
A Phase 3 study testing Acyclovir 800 MG and Radiotherapy and chemotherapy in people with Drug Use for Unapproved Schedule, run by Kuwait Cancer Control Center at 1 site in Kuwait.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Drug Use for Unapproved Schedule
- What is being tested?
- Acyclovir 800 MG and Radiotherapy and chemotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteKuwait
- Study dates
- 1 May 2018to May 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Phase III Study in EBV Positive Locally Advanced Nasopharyngeal Carcinoma Treated With Concurrent Chemo-radiotherapy With or Without Anti-Viral Drug
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.
- Conditions
- Drug Use for Unapproved Schedule
- Being tested
- Acyclovir 800 MG, Radiotherapy and chemotherapy
- Keywords
- EBV, Nasopharyngeal Carcinoma
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acyclovir 800 MGDrug
Acyclovir tablets 800 mg per day during the whole course of treatment Or Placebo.
Radiotherapy and chemotherapyCombination product
Concurrent chemoradiotherapy which consisted of Cisplatin 40 mg/m2 weekly or 100mg/m2 every 3 weeks with IMRT 70Gy/35 fractions.
| Study group | Role | What they receive |
|---|---|---|
| Antiviral Drug with Chemoradiotherapy | Experimental | Antiviral therapy Acyclovir 800 mg per day during the whole course of treatment. Receives: Drug: Acyclovir 800 MG; Combination Product: Radiotherapy and chemotherapy |
| Chemoradiotherapy | Other | Patients will receive concurrent chemoradiotherapy which consisted of Cisplatin 40 mg/m2 weekly or 100mg/m2 every 3 weeks with IMRT 70Gy/35 fractions. Receives: Combination Product: Radiotherapy and chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Eliminated EBV titre as assessed by quantitative PCR-DNA in patients with NPC.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start1 May 2018
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Use for Unapproved ScheduleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuwait Cancer Control Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Alsaleh,MD, Kuwait Cancer Control Center
- Investigators
- Khaled AlSaleh, M.D, Principal investigator, Chairman, Radiation Oncology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656965
- Sponsor's protocol ID
- RODKCCC
- Status last verified
- Aug 2018
- First submitted
- 26 Aug 2018
- Last updated
- 4 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase III Study in EBV Positive Locally Advanced Nasopharyngeal Carcinoma Treated With Concurrent Chemo-radiotherapy With or Without Anti-Viral Drug
- ClinicalTrials.gov ID
- NCT03656965
- Acronym / sponsor ID
- RODKCCC
- Conditions
- Drug Use for Unapproved Schedule
- Keywords
- EBV, Nasopharyngeal Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kuwait Cancer Control CenterUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 4 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antiviral Drug with Chemoradiotherapy | Experimental | Drug: Acyclovir 800 MG, Combination Product: Radiotherapy and chemotherapyAntiviral therapy Acyclovir 800 mg per day during the whole course of treatment. |
| Chemoradiotherapy | Other | Combination Product: Radiotherapy and chemotherapyPatients will receive concurrent chemoradiotherapy which consisted of Cisplatin 40 mg/m2 weekly or 100mg/m2 every 3 weeks with IMRT 70Gy/35 fractions. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acyclovir 800 MGAcyclovir tablets 800 mg per day during the whole course of treatment Or Placebo. | Drug | Antiviral Drug with Chemoradiotherapy |
| Radiotherapy and chemotherapyConcurrent chemoradiotherapy which consisted of Cisplatin 40 mg/m2 weekly or 100mg/m2 every 3 weeks with IMRT 70Gy/35 fractions. | Combination product | Antiviral Drug with Chemoradiotherapy, Chemoradiotherapy |
Primary outcome
Number of participants with Eliminated EBV titre as assessed by quantitative PCR-DNA in patients with NPC.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khaled AlSaleh, M.D principal investigator
Chairman, Radiation Oncology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acyclovir 800 MG and Radiotherapy and chemotherapy in people with Drug Use for Unapproved Schedule, run by Kuwait Cancer Control Center at 1 site in Kuwait.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kuwait. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Eliminated EBV titre as assessed by quantitative PCR-DNA in patients with NPC. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2018.