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| ID | Type | Description | Link |
|---|---|---|---|
| 2010/00064 | Other Identifier | NHG Domain Specific Review Board |
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| Name | Class |
|---|---|
| National Cancer Centre, Singapore | OTHER |
| Yonsei University | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TS-1 with cisplatin | Experimental | 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. |
|
| TS-1 with oxaliplatin | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TS-1 with cisplatin | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate (RR) | To determine the response rate of cisplatin/TS-1 and oxaliplatin/TS-1 combination in predicted 'responders' | 1 year |
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Inclusion Criteria:
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)
Exclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Peng Yong, MRCP,MB ChB | Contact | 65 6772 4670 | Wei_Peng_Yong@nuhs.edu.sg |
| Name | Affiliation | Role |
|---|---|---|
| Wei Peng Yong, MRCP, MB ChB | National University Hospital, Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University Hospital | Recruiting | Singapore | Singapore | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15221596 | Background | 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. | |
| 19262709 | Background | Koizumi W. Chemotherapy for advanced gastric cancer: review of global and Japanese status. Gastrointest Cancer Res. 2007 Sep;1(5):197-203. |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C103828 | titanium silicide |
| D002945 | Cisplatin |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| TS-1 with oxaliplatin |
| Drug |
|
|
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D056831 |
| Coordination Complexes |
| D009930 | Organic Chemicals |