Completed

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

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What is being tested

S-1

+ Cisplatin

+ S-1

Drug
Who is being recruted

Digestive System Diseases+5

+ Digestive System Neoplasms

+ Gastrointestinal Diseases

From 18 to 75 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorSun Yat-sen University
Last updated: January 23, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

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%.

Principal SponsorSun Yat-sen University
Last updated: January 23, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

576 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsNeoplasmsNeoplasms by SiteStomach DiseasesStomach Neoplasms

Criteria

Inclusion Criteria: histologically confirmed unresectable advanced or recurrent diffuse-type or mixed-type gastric adenocarcinoma or gastroesophageal junction adenocarcinoma. 18 years old to 75 years old, able to conduct oral administration. Measurable disease or non-measurable but evaluable disease, according to the Response Evaluation Criteria in Solid Tumours(RECIST 1.1) No palliative chemotherapy and radiotherapy. Previous adjuvant or neoadjuvant chemotherapy , if applicable, more than 12 months. ECOG systemic status score of 0 to 2. normal organ function, that meet the following criteria: ALT and AST(≤2.5 times ULN (≤5 times ULN in patients with liver metastases) ALP ≤ 2 times ULN ; (for patients with liver metastases can be no limit to the ALP). Total bilirubin ≤ 1 times ULN. Absolute neutrophil count ≥ 2.0 × 10^9 / L. Platelet count ≥ 100 × 10^9 / L. Hemoglobin ≥ 80g / L. Creatinine ≤ 1.25 times ULN. The estimated creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula). Signed informed consent, treatment, follow-up and inspection in accordance with the study protocol. Life expectancy greater than 3 months. At least 3 weeks after major surgery. Exclusion Criteria: Previous adjuvant or neoadjuvant chemotherapy within the prescribed time the investigator determines that the patient is not suitable for participation in this study, and specifically includes (but is not limited to): The past five years there have been other malignancies, but after appropriate treatment of cervical carcinoma in situ and non-melanoma skin cancer. brain metastases or leptomeningeal metastasis. myocardial infarction (within the past six months), severe unstable angina, congestive heart failure. Serious complications (including paralytic ileus, intestinal obstruction, interstitial pneumonia, lung fibrosis, beyond the control of diabetes, renal insufficiency and cirrhosis of the liver, etc.). Chronic nausea, vomiting, or diarrhea (per day greater than or equal to 4 times or watery stools). Gastrointestinal bleeding, and need for frequent blood transfusions. human immunodeficiency virus (HIV) carrier or suffering from AIDS (AIDS). Suffering from a mental illness. neuropathy severity ≥grade 2 . Infectious disease or inflammation, body temperature ≥ 38 ℃. Cisplatin, oxaliplatin, or S-1 allergy. Pregnancy or breast-feeding women. refused to take appropriate contraceptive measures (including male patients). Under experimental drug within 4 weeks. Under other anti-cancer treatment. HER2 IHC(3+) or IHC(2+) /FISH(+)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Sun Yat-sen University Cancer Center

Guangzhou, ChinaOpen Sun Yat-sen University Cancer Center in Google Maps
CompletedOne Study Center