Weekly Plasma EBV DNA for Non-metastatic Nasopharyngeal Carcinoma
Nasopharyngeal carcinoma (NPC) is an endemic malignancy in Southern China, Hong Kong, Taiwan, Singapore and Malaysia. It is highly associated with Epstein-Barr virus (EBV). Radiation therapy alone is indicated for early stage I to II diseases while concurrent chemoradiation is required for more advanced stage III to IVB diseases. Intensity-modulated radiation therapy (IMRT) is the standard radiation technique for NPC, in virtue of its superior target coverage and dose sparing to adjacent critical organs-at-risks.
Plasma EBV DNA and other novel plasma biomarkers have been extensively investigated in NPC. Previous studies have proven their predictive and prognostic values in NPC diagnosis, surveillance and survival outcomes.
Investigators would like to investigate the roles of plasma biomarkers including plasma EBV DNA on treatment response evaluation, survival and prognosis on NPC, in the modern era of precision radiation therapy. This will help provide important information on refining on the current edition of AJCC/UICC staging classification.
調査の概要
状態
条件
詳細な説明
Patients with histologically confirmed previously untreated NPC are be recruited to join tis study. The study has obtained approval from local institutional review board.
After written informed consent, baseline investigations including blood tests for routine hematology, biochemistry and plasma EBV DNA will be taken. Only 3ml of EDTA blood will be taken for plasma EBV DNA and other potential biomarkers. Patients will also undergo baseline imaging investigations including positron-emission tomography with integrated computed tomography (PET-CT) and magnetic resonance imaging (MRI) of the head and neck regions. An routine nasoendoscopy and nasopharyngeal biopsies will be obtained to confirm and delineate the mucosal extent of the disease.
If confirmed non-metastatic, patients will be treated with IMRT using 7-9 radiation beams. A total dose of 70Gy in 33-35 fractions over 6.5 to 7 weeks will be given. For advanced stage III to IVB diseases, concurrent chemoradiation using cisplatin 100mg/m2 on Day 1, 22 and 43 of IMRT followed by 3 cycles of adjuvant chemotherapy with cisplatin 80mg/m2 on Day 1 and 5-FU 1000mg/m2 from Day 1 to Day 4 every 4 weeks for 3 more cycles starting 4 weeks after completion of IMRT will also be given. Some patients will also receive induction chemotherapy with cisplatin100mg/m2 on Day 1 and 5-FU 1000mg/m2 on Day 1 to 5, administered every 3 weeks for 3 cycles before commencement of chemoradiation, at the discretion of treating oncologists if the primary tumours are close to critical organs e.g. brainstem, optic chiasm or optic nerves.
After treatment patients will undergo nasopharyngeal biopsies, patients will undergo nasopharyngeal biopsies again at 8 weeks after completion of IMRT to confirm histological complete local remission. Blood will be taken again on the same day for plasma EBV DNA and other potential biomarkers. Additional biopsies and salvage local treatment e.g. brachytherapy, stereotactic or IMRT boost will be offered to patients who have persistent local disease at 12 weeks after completion of IMRT. If complete local remission is confirmed, patient will have regular follow up every 3 to 4 months for surveillance and survival outcomes. Regular imaging with MRI and CT scans every 3 to 4 months will also be arranged as well. Plasma EBV DNA will be measured at weekly intervals until EBV DNA is undetectable.
For those with metastatic diseases, systemic chemotherapy (platinum-based chemotherapy) will be offered. Blood taking for plasma EBV DNA and other potential biomarkers at baseline before chemotherapy commencement and then after every 3 cycles will be arranged. Imaging examinations with CT and MRI scans will be arranged at baseline and then after 3-4 cycles of chemotherapy for tumour response evaluation.
The trend of baseline and serial plasma EBV DNA will be monitored prospectively.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Hong Kong、香港
- 募集
- Department of Clinical Oncology, Queen Mary Hospital
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コンタクト：
- Victor Lee, FRCR
- 電話番号：852-2255-4352
- メール：vhflee@hku.hk
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Patients with histologically confirmed previously untreated nasopharyngeal carcinoma
Exclusion Criteria:
- Patients who are pregnant or lactating
- Patients who are not mentally capable of giving written informed consent
- Patients with performance status ECOG=3 or above or patients who are expected not able to tolerate radiation therapy and/or chemotherapy
- Patients who refuse active treatment for their nasopharyngeal carcinoma
- Patients who cannot comply with radiation therapy and/or chemotherapy for their nasopharyngeal carcinoma
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
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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無増悪生存
時間枠：3年
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無増悪生存期間は、NPC の診断日から NPC の進行日または何らかの原因による死亡日のいずれか早い方まで計算されます。
|
3年
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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無遠隔転移生存
時間枠：3年
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遠隔転移のない生存期間は、NPC の診断日から、遠隔転移の日付または何らかの原因による死亡のいずれか早い方の日まで計算されます。
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3年
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Overall survival
時間枠：3 years
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Overall survival is calculated from the date of diagnosis of NPC to the date of death from any cause
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3 years
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協力者と研究者
出版物と役立つリンク
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
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