Efficacy and Safety of S-1 Plus Oxaliplatin in First-line Treatment of Ederly Patients With Advanced Gastric Cancer

Study Overview
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Brief Summary
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Elderly patients have poor tolerance and physical condition, we will prove 2-week schedule of oxaliplatin plus S-1 have a good efficacy and a better safety for elderly patients with advanced or recurrent gastric cancer.

Detailed Description
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3-week plan of S-1 plus Oxaliplatin has been widely used,but it also has cumulative toxicity.Meanwhile elderly patients have poor tolerance and physical condition, we will prove 2-weeks schedule of oxaliplatin plus S-1 have a good efficacy and a better safety for elderly patients with advanced or recurrent gastric cancer.Untreated elderly patients with advanced or recurrent gastric cancer will receive Oxaliplatin 85 mg/m2 (D1, q2w) and S-1(40mg BID for body surface area < 1.25 m2; 50mg BID for body surface area of 1.25-1.5m2; and 60mg BID for body surface area >1.5 m2; D1-10, q2w) as the first-line treatment. We will investigate the efficacy and safety of the combination treatment, and expect to provide a good effective treatment plan and a better safety for elderly patients with advanced or recurrent gastric cancer in China.The primary endpoint is progression-free survival(PFS), and the secondary endpoints are objective response rate(ORR), overall survival(OS) and the safety.

Official Title
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The Efficacy and Safety of S-1 Plus Oxaliplatin in First-line Treatment of Ederly Patients With Advanced or Recurrent Gastric Cancer

Conditions
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S-1 Plus Oxaliplatin

Intervention / Treatment
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* Drug: S-1,Oxaliplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed unresectable or recurrent gastric or gastroesophageal junction adenocarcinoma; Aged≥60 ability of oral administration; CT or MRI can be used to assess measurable or non-measurable lesions according to the criteria of Response Evaluation Criteria In Solid Tumours (RECIST 1.1); Untreated more than 12 months after the last adjuvant/neoadjuvant chemotherapy; ECOG=0-2; Available organ function: ALT≤2.5xULN;AST≤2.5xULN;If patients have hepaticmetastasis,ALT≤2.5xULN,AST≤2.5xULN;ALP≤2xULN;TBIL≤1.0xULN;NEUT≥1.5×109/L;PLT≥100×109/L;Hb≥90g/L;Creatinine≤1.0xULN;Creatinine Clearance≥60ml/min Informed consent; Expected survival more than 3 months;More than 3 weeks after major surgery. Exclusion Criteria: Neoadjuvant and/or adjuvant have been treated with more than two plans; In the past two years, the total dose of oxaliplatin≥800mg/m2; Other cancers in the past 5 years,except for cervical carcinoma in situ or non-melanoma skin cancer; Symptomatic brain metastases or soft meningeal metastasis; Myocardial infarction (in the last 6 months), severe instability angina, congestive heart failure; Serious complications (including intestinal paralysis, gastrointestinal obstruction, interstitial pneumonia, pulmonary fibrosis, uncontrolled diabetes, renal insufficiency and cirrhosis); Chronic nausea, vomiting or diarrhea (more than 4 times per day, or watery);Gastrointestinal bleeding requires regular blood transfusion;HIV or AIDS; Mental illness; Neuropathy grade≥2;Infectious diseases or inflammation, temperature≥38℃; Known allergy to drugs in the study; Pregnant or lactating women; Both male and female subjects of potential fertility have to agree effective birth control during the entire study; Experimental drugs used no more than 4 weeks; Other conditions the researchers considered ineligible for the study.

Ages Eligible for Study
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Minimum Age: 60 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
Interventional Model Description: Single Group Assignment Eledrly Patients with Untreated Advanced or Recurrent Gastric Cancer
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S-1 Plus Oxaliplatin<br>Oxaliplatin 85 mg/m2 (D1, q2w) and S-1 (40mg BID for body surface area < 1.25 m2; 50mg BID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area >1.5 m2; D1-10, q2w) | Drug: S-1,Oxaliplatin<br>* Oxaliplatin 85 mg/m2 (D1, q2w) and S-1 (40mg BID for body surface area < 1.25 m2; 50mg BID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area >1.5 m2; D1-10, q2w)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression-free survival | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Objective response rate | 6 months | 
| OS | Overall survival | 1 year | 
| The number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Safety | 1 year | 

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