Feasibility Study of SOL (S-1,Oral Leucovorin,and Oxaliplatin) in Patients With Advanced Gastric Cancer

Study Overview
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Brief Summary
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In China, S-1 is an novel oral fluoropyrimidine with demonstrated high efficacy on gastrointestinal cancer. The new regimen with oxaliplatin and leucovorin is expected to achieve more encouraging efficacy on gastric cancer. This study is aimed to evaluate the feasibility of the SOL regimen on efficacy and tolerability on Chinese patients with advanced gastric cancer.

Official Title
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A Safety and Efficacy Study of S-1, Oxaliplatin, and Leucovorin (SOL) in Patients With Advanced Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: S-1, leucovorin, oxaliplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18 years old Histologically or cytologically documented gastric adenocarcinoma Performance status (ECOG scale): 0-2 Life expectancy ≥ 3 months No previous treatment(including: radiotherapy,chemotherapy and immunotherapy) Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive immunotherapy) for adjuvant or neoadjuvant treatment for non-metastatic (M0) disease has been completed within 6 months prior to initiation of study treatment. WIth Measurable Target lesion Patients should sign a written informed consent before study entry Exclusion Criteria: History of hypersensitivity to fluoropyrimidines, S-1, oxaliplatin or the ingredients product Inadequate hematopoietic function: WBC≦5,000/mm3; ANC≦2,000/mm3; Platelet≦100,000/mm3 Inadequate organ function which is defined as below: Total bilirubin >2 pper limit of normal range (ULN); ALT / AST > 2.5 upper limit of normal range (ULN) (>5.0 x ULN if hepatic metastasis); serum creatinine > 2 upper limit of normal range (ULN); Symptomatic peripheral neuropathy ≥ NCI CTC AE grade 1; Receiving a concomitant treatment with other fluoropyrimidines or fluorocytosine; Pregnancy or lactation women, or women with suspected pregnancy or men unless using a reliable and appropriate contraceptive method; Mental status is not fit for chemotherapy therapy presence of serious concomitant illness which might be aggravated by study medication; History of ventricular arrhythmia or congestive heart failure; Active cardiac disease e.g. decompensate myocardial infarction within the 6-month period preceding entry into the study; Significant co-morbid medical conditions, including, but not limited to, Chronic obstructive pulmonary disease, interstitial pneumonia ,pulmonary heart failure, renal failure, hepatic failure, haemorrhagic peptic ulcer, mechanical, paralytic or poor control diabetes

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SOL, single arm<br>S-1 combined with leucovorin and oxaliplatin | Drug: S-1, leucovorin, oxaliplatin<br>* S-1 (20mg), capsule, 40-60mg, bid, p.o., day1-14； Leucovorin (15 mg), tablet, 30mg,Bid, p.o., day1-14; Oxaliplatin (50 mg), injection 85mg/m2, day1.<br>* Other names: L-OHP (50mg);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | Evaluate the objective response rate followed by RECIST 1.1. | 6-8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Investigators graded all adverse events and toxic effects according to the National Cancer Institute's Common Toxicity Criteria, The number of Participants with adverse events will be recorded at each treatment visit. | 1 year | 
| Overall survival |  | 3 year | 
| Progress free survival | Tumor assessment will be performed every 3 cycles (9 weeks) from the start of treatment until progression or as for the metastatic site developed during the study (including clinical suspicion). In order to confirm objective tumor response, additional confirmatory scan should be obtained at least 4 weeks following the first radiological evidence of tumor response. | up to 9 weeks | 
| Disease control rate | To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria | up to 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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S-1, Oxaliplatin, Leucovorin, Gastric Cancer