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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01824459
• Other study ID #: SOX-DGCA
• Status: Completed
• Phase: Phase 3
• Start date: April 2013
• Est. completion date: December 1, 2018

Study information

• Verified date: January 2019
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 576
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. histologically confirmed unresectable advanced or recurrent diffuse-type or mixed-type gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.

2. 18 years old to 75 years old, able to conduct oral administration.

3. Measurable disease or non-measurable but evaluable disease, according to the Response Evaluation Criteria in Solid Tumours(RECIST 1.1)

4. No palliative chemotherapy and radiotherapy. Previous adjuvant or neoadjuvant chemotherapy , if applicable, more than 12 months.

5. ECOG systemic status score of 0 to 2.

6. normal organ function, that meet the following criteria:

1. ALT and AST(=2.5 times ULN (=5 times ULN in patients with liver metastases)

2. ALP = 2 times ULN ; (for patients with liver metastases can be no limit to the ALP).

3. Total bilirubin = 1 times ULN.

4. Absolute neutrophil count = 2.0 × 10^9 / L.

5. Platelet count = 100 × 10^9 / L.

6. Hemoglobin = 80g / L.

7. Creatinine = 1.25 times ULN.

8. The estimated creatinine clearance = 60 mL/min (Cockcroft-Gault formula).

7. Signed informed consent, treatment, follow-up and inspection in accordance with the study protocol.

8. Life expectancy greater than 3 months.

9. At least 3 weeks after major surgery.

Exclusion Criteria:

1. Previous adjuvant or neoadjuvant chemotherapy within the prescribed time

2. the investigator determines that the patient is not suitable for participation in this study, and specifically includes (but is not limited to):

1. The past five years there have been other malignancies, but after appropriate treatment of cervical carcinoma in situ and non-melanoma skin cancer.

2. brain metastases or leptomeningeal metastasis.

3. myocardial infarction (within the past six months), severe unstable angina, congestive heart failure.

4. Serious complications (including paralytic ileus, intestinal obstruction, interstitial pneumonia, lung fibrosis, beyond the control of diabetes, renal insufficiency and cirrhosis of the liver, etc.).

5. Chronic nausea, vomiting, or diarrhea (per day greater than or equal to 4 times or watery stools).

6. Gastrointestinal bleeding, and need for frequent blood transfusions.

7. human immunodeficiency virus (HIV) carrier or suffering from AIDS (AIDS).

8. Suffering from a mental illness.

9. neuropathy severity =grade 2 .

10. Infectious disease or inflammation, body temperature = 38 ?.

3. Cisplatin, oxaliplatin, or S-1 allergy.

4. Pregnancy or breast-feeding women.

5. refused to take appropriate contraceptive measures (including male patients).

6. Under experimental drug within 4 weeks.

7. Under other anti-cancer treatment.

8. HER2 IHC(3+) or IHC(2+) /FISH(+)

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Neoplasms
• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• S-1
S-1:40~60mg bid,d1~14 q3W
• Oxaliplatin
oxaliplatin:130mg/m2,iv drip for 2h,d1,q3W
• Cisplatin
cisplatin:60mg/m2,iv drip ,d1,q3W

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Taiho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	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	1-1.5 year
Secondary	Objective response rate	The primary endpoint is objective response rate,which equals CR+PR.	1 year
Secondary	time to treatment failure (TTF)	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.	6 months
Secondary	progression-free survival (PFS)	The duration is from the randomized time to disease progression or death due to any reason.	6 months
Secondary	Adverse events (AE)		1-1.5 years