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.
研究概览
详细说明
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
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
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Singapore、新加坡
- 招聘中
- National University Hospital
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接触:
- Wei Peng Yong, MRCP, MB ChB
- 电话号码:65 6772 4670
- 邮箱:Wei_Peng_Yong@nuhs.edu.sg
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的: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. |
其他名称:
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实验性的: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. |
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Response Rate (RR)
大体时间: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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合作者和调查者
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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TS-1 with cisplatin的临床试验
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Chonnam National University Hospital完全的
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Cancer Institute and Hospital, Chinese Academy...完全的
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The First Affiliated Hospital of Soochow UniversityFundamenta Therapeutics, Ltd.招聘中
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Asan Medical CenterNational Cancer Center, Korea; Chonbuk National University Hospital; Samsung Medical Center; Chonnam... 和其他合作者完全的