- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03656965
EBV Positive Nasopharyngeal Carcinoma Treated With Concurrent Chemo-radiotherapy With or Without Anti-Viral Drug
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
-
-
-
Kuwait, Kuwait
- Kuwait Cancer control center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Antiviral Drug with Chemoradiotherapy
Antiviral therapy Acyclovir 800 mg per day during the whole course of treatment.
|
Acyclovir tablets 800 mg per day during the whole course of treatment Or Placebo.
Concurrent chemoradiotherapy which consisted of Cisplatin 40 mg/m2 weekly or 100mg/m2 every 3 weeks with IMRT 70Gy/35 fractions.
|
|
Andet: 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.
|
Concurrent chemoradiotherapy which consisted of Cisplatin 40 mg/m2 weekly or 100mg/m2 every 3 weeks with IMRT 70Gy/35 fractions.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Number of participants with Eliminated EBV titre as assessed by quantitative PCR-DNA in patients with NPC.
Tidsramme: 3 months
|
3 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Khaled AlSaleh, M.D, Chairman, Radiation Oncology Department
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer efter sted
- Neoplasmer, kirtel og epitel
- Pharyngeale neoplasmer
- Otorhinolaryngologiske neoplasmer
- Neoplasmer i hoved og hals
- Nasopharyngeale sygdomme
- Pharyngeale sygdomme
- Stomatognatiske sygdomme
- Otorhinolaryngologiske sygdomme
- Nasopharyngeale neoplasmer
- Karcinom
- Nasopharyngealt karcinom
- Anti-infektionsmidler
- Antivirale midler
- Acyclovir
Andre undersøgelses-id-numre
- RODKCCC
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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produkt fremstillet i og eksporteret fra U.S.A.
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