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.
調査の概要
状態
研究の種類
入学 (予想される)
段階
- フェーズ 3
連絡先と場所
研究場所
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Kuwait、クウェート
- Kuwait Cancer control center
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Antiviral Drug with Chemoradiotherapy
Antiviral therapy Acyclovir 800 mg per day during the whole course of treatment.
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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.
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他の：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.
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Concurrent chemoradiotherapy which consisted of Cisplatin 40 mg/m2 weekly or 100mg/m2 every 3 weeks with IMRT 70Gy/35 fractions.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Number of participants with Eliminated EBV titre as assessed by quantitative PCR-DNA in patients with NPC.
時間枠：3 months
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3 months
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協力者と研究者
捜査官
- 主任研究者：Khaled AlSaleh, M.D、Chairman, Radiation Oncology Department
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。