Symptoms and General Pathology

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Neoplasms

Digestive System Diseases

Rare Diseases

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Stomach Neoplasms

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Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

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Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Oxaliplatin

Cisplatin

S-1：40\~60mg bid，d1\~14 q3W cisplatin：60mg/m2，iv drip ，d1,q3W Number of Cycles: until progression or unacceptable toxicity develops.

S-1：40\~60mg bid，d1\~14 q3W oxaliplatin：130mg/m2，iv drip for 2h，d1,q3W Number of Cycles: until progression or unacceptable toxicity develops.

oxaliplatin：130mg/m2，iv drip for 2h，d1,q3W

ruihua xu, Professor

The purpose of this study is to evaluate the effectiveness and safety of S-1+Oxaliplatin vs.S-1+Cisplatin First-line Treatment in Advanced or Recurrent Non-intestinal Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma Patients.

The primary endpoint is Overall survival time (OS).Secondary endpoints are overall response rate (ORR), time to treatment failure (TTF),progression free survival (PFS)and the adverse reactions(AE) of the two groups .

Study design:

This is a prospective randomized control study.

Sample size:

Sample size considerations were based on the survival end point. The improvement in median survival from 10 months in the S-1+cisplatin arm to 13 months in the S-1+oxaliplatin arm was considered clinically relevant in this patient population. A total of 576 patients were required for a two-tailed log-rank test at the 5% significance and at least 80% power. The planned enrolled time was 48 months and 1 year of follow up, and a drop-out rate of 5%.

S-1+Oxaliplatin vs.S-1+Cisplatin First-line Treatment of Advanced or Recurrent Non-intestinal Type Gastric Adenocarcinoma Patients

A Randomized, Open, Multi-center, Phase III Study of S-1+Oxaliplatin vs.S-1+Cisplatin First-line Treatment in Advanced or Recurrent Non-intestinal Type Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma Patients

OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 12 weeks till death or lost

The primary endpoint is objective response rate,which equals CR+PR.

The duration is from the randomized time to treatment termination due to any reason. The reasons may include disease progression, treatment toxicity, patient selection or death.

The duration is from the randomized time to disease progression or death due to any reason.

Taiho Pharmaceutical Co., Ltd.

Sun Yat-sen University

vice president of SunYat-sen University Cancer Center,head of medical oncology department

Micronutrients

Hematinics

Vitamins

Tegafur

Leucovorin

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Antimetabolites

Folate

Vitamin B9

All patients were orally treated with S-1 in doses of 40 mg (body surface area (BSA)\<1.25 m2), 50 mg (1.25≤BSA\<1.50 m2) and 60 mg (BSA≥1.50 m2) b.i.d. on days 1-7 in combination with LV given simultaneously at a ﬁxed dose of 25 mg b.i.d. on days 1-7, followed by a 7 day rest. Treatment courses were repeated every 2 weeks.

LV is given simultaneously at a ﬁxed dose of 25 mg b.i.d. on days 1-7, followed by a 7 day rest.

Ruihua Xu, Professor

The purpose of this study is to evaluate the effectiveness and safety of S-1 plus Leucovorin (1 week on and 1 week off) as first-line treatment for patients with metastatic and recurrent gastric cancer.

Patients enrolled in this study were orally treated with S-1 in doses of 40 mg (body surface area (BSA)\<1.25 m2), 50 mg (1.25≤BSA\<1.50 m2) and 60 mg (BSA≥1.50 m2) b.i.d. on days 1-7 in combination with LV given simultaneously at a ﬁxed dose of 25 mg b.i.d. on days 1-7, followed by a 7 day rest. Treatment courses were repeated every 2 weeks. Treatment was continued until progressive disease (PD), unacceptable toxicity or patient refusal.

Study of S-1 Plus LV for Advanced Gastric Cancer

Phase II Study of S-1 Plus Leucovorin (1 Week on and 1 Week Off) as First-line Treatment for Patients With Metastatic and Recurrent Gastric Cancer

The primary endpoint is overall response rate,which equals the rate of patients with CR+PR.

Progression-free survival (PFS) was determined from the date of treatment to progression or death

Overall survival (OS) was calculated from the date of treatment to death from any cause or the last date of follow-up.

Time to treatment failure (TTF) was determined from the date of treatment to progression, death, refusal or interruption due to adverse events.

Disease control rate equals the rate of patients with CR+PR+SD.

All treatment-related adverse events (AEs) were categorized according to the National Cancer Institute's Common Terminology Criteria for Adverse Events.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
S-1+Oxaliplatin vs.S-1+Cisplatin First-line Treatment of Advanced or Recurrent Non-intestinal Type Gastric Adenocarcinoma Patients	NCT01824459	Gastric Cancer	S-1 Oxaliplatin Cisplatin	18 Years - 75 Years	Sun Yat-sen University
S-1+Oxaliplatin vs.S-1+Cisplatin First-line Treatment of Advanced or Recurrent Non-intestinal Type Gastric Adenocarcinoma Patients	NCT01824459	Gastric Cancer	S-1 Oxaliplatin Cisplatin	18 Years - 75 Years	Sun Yat-sen University
Study of S-1 Plus LV for Advanced Gastric Cancer	NCT02090153	Gastric Cancer	S-1 LV	18 Years -	Sun Yat-sen University

Spots Global Cancer Trial Database for os,

Every month we try and update this database with for os, cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for os,

Every month we try and update this database with for os, cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for os, cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.