A Study of Genomic-guided 'Standard-of-care' Chemotherapy for in Advanced Gastric Cancer Patients (3G)
A Phase II Study of Genomic-guided 'Standard-of-care' Chemotherapy for in Advanced Gastric Cancer Patients
This is an open, non-randomized, multicenter Phase II study evaluating cisplatin plus TS-1 or oxaliplatin plus TS-1 as first-line therapy in predicted 'responder' to platinum and fluoropyrimidine.
This study is planned in 3 centers in Singapore and Korea. A total of 30 subjects will be enrolled into each treatment arms. Each centers will recruit 15-25 subjects predicted to be 'responder' to platinum and fluoropyrimidine. The study will consist of a prescreening period, a screening period and a treatment period. A fresh tumour biopsy sample will be obtained during the prescreening period for gene expression profiling.
As this is a genomics guided trial, obtaining tissue biopsies is vital to the conduct of the trial.
Patients will have the primary in situ (requirement for entry into trial), endoscopic biopsy performed prior to 1st cycle.
調査の概要
詳細な説明
Gastric cancer is the world's second leading cause of cancer death. For patients with unresectable disease or recurrent disease after surgery, the main therapeutic option is chemotherapy. Chemotherapy can improve survival and quality of life in patients with advanced disease when compared with best supportive care alone.
Despite a large number of randomized trials, there is no consensus as to the best agent or regimen. In general, combination chemotherapy regimens provide higher response rates than do single agent, however, this translates into only a modest improvement in outcome with a trade off in increased treatment toxicities. The key challenge in managing patients with advanced gastric cancer is to identify the appropriate drugs for patients who might benefit for palliative chemotherapy.
Gastric cancer is a heterogeneous disease with differing chemosensitivities to anti-cancer drugs. Current selection of standard therapy is often empirical. Gene expression profiling has been shown to have the capability to dissect this heterogeneity allowing for sub-classification and risk-stratification of cancers according to their biological features and clinical outcome. Utilising gene expression data coupled with in-vitro, in-vivo or clinical response data is a promising strategy that may enable clinicians to match the right drug to the right patient.
The purpose of the study are:
- Assess the feasibility of genomic-guided therapy
- Evaluated treatment response of standard-of-care chemotherapy in an enriched patient groups defined as 'responder' based on genomic-guided therapy
研究の種類
入学 (予想される)
段階
- フェーズ2
連絡先と場所
研究場所
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Singapore、シンガポール
- 募集
- National University Hospital
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コンタクト：
- Wei Peng Yong, MRCP, MB ChB
- 電話番号：65 6772 4670
- メール：Wei_Peng_Yong@nuhs.edu.sg
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参加基準
適格基準
就学可能な年齢
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:
- Histologically or cytologically documented locally advanced, metastatic or recurrent gastric cancer for which convention therapy of a platinum/fluoropyrimidine combination is indicated
- Predicted 'responder' to platinum and fluoropyrimidine based on tumour expression signature derived from in-vitro sensitivity array
- At least one measurable defined by RECIST
- Age >=21 years old
- Performance status (ECOG) 0-2
- Life expectancy >3 months
- No significant problems for oral intake and drug administration
- Adequate organ functions:
bone marrow function (ANC = 1,500/uL, Platelet = 100,000/ uL, Hb = 8.0 g/dl) renal function: serum creatinine = UNL (if serum creatinine > ULN, creatinine clearance should be = 60 mL/min) hepatic function (Total bilirubin < 2 x UNL and AST/ALT levels < 3 x ULN without liver metastasis, total bilirubin < 3x ULN and AST/ALT levels < 5 x ULN with liver metastasis)
- Recovery from relevant toxicity to previous treatment before study entry
- Ability to understand and willingness to sign a written informed consent before study entry
Exclusion Criteria:
- Prior chemotherapy for gastric cancer except neoadjuvant or adjuvant systemic therapy if terminated at least 6 months before the start of treatment in this study
- Prior radiotherapy was administered to target lesions selected for this study
- Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence)
- Presence of symptomatic or progressing CNS metastasis
- Serious illness or medical conditions:
Congestive heart failure (NYHA class III or IV), unstable angina or myocardial infarction within the past 3 months Hepatic cirrhosis (= Child class B) Psychiatric disorder that may interfere with protocol compliance Active infection
- Known hypersensitivity to platinum or fluoropyrimidine.
- Pregnant or lactating woman. Women of child bearing potential not using a contraceptive method
- Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential
- Any patients judged by the investigator to be unfit to participate in the study
- Predicted 'non-responder' to platinum and fluoropyrimidine based on tumour expression signature derived from in- vitro sensitivity array
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：非ランダム化
- 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：TS-1 with cisplatin
Chemotherapy injection (60mg/m2 cisplatin) will be given on day 1. 14 days of Oral TS-1 (40mg/m²) will be prescribed. Subjects will take it after breakfast and evening meal on Day 1-14 of a 3-weekly treatment cycle. Each cycle is about 21 days. |
他の名前：
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実験的：TS-1 with oxaliplatin
Chemotherapy injection (100mg/m2 oxaliplatin) will be given on day 1. 14 days of Oral TS-1 (40mg/m²) will be prescribed. Subjects will take it after breakfast and evening meal on Day 1-14 of a 3-weekly treatment cycle. Each cycle is about 21 days. |
他の名前：
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Response Rate (RR)
時間枠：1 year
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To determine the response rate of cisplatin/TS-1 and oxaliplatin/TS-1 combination in predicted 'responders'
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1 year
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協力者と研究者
出版物と役立つリンク
一般刊行物
- Arai W, Hosoya Y, Hyodo M, Yokoyama T, Hirashima Y, Yasuda Y, Nagai H, Shirasaka T. Alternate-day oral therapy with TS-1 for advanced gastric cancer. Int J Clin Oncol. 2004 Jun;9(3):143-8. doi: 10.1007/s10147-004-0381-9.
- Koizumi W. Chemotherapy for advanced gastric cancer: review of global and Japanese status. Gastrointest Cancer Res. 2007 Sep;1(5):197-203.
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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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