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

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
S-1
Oxaliplatin
Cisplatin
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Non-intestinal type gastric cancer, Advance Gastric Cancer, Recurrent Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, SOX, S-1+Oxaliplatin, OS,, ORR,, PFS,, TTF,, safety

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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(+)

Sites / Locations

  • Sun Yat-sen University Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

S-1 + cisplatin(SP)

S-1+Oxaliplatin（SOX）

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Objective response rate
The primary endpoint is objective response rate,which equals CR+PR.
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.
progression-free survival (PFS)
The duration is from the randomized time to disease progression or death due to any reason.
Adverse events (AE)

Full Information

First Posted
April 1, 2013
Last Updated
January 18, 2019
Sponsor
Sun Yat-sen University
Collaborators
Taiho Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01824459
Brief Title
S-1+Oxaliplatin vs.S-1+Cisplatin First-line Treatment of Advanced or Recurrent Non-intestinal Type Gastric Adenocarcinoma Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Taiho Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Non-intestinal type gastric cancer, Advance Gastric Cancer, Recurrent Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, SOX, S-1+Oxaliplatin, OS,, ORR,, PFS,, TTF,, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
576 (Actual)

8. Arms, Groups, and Interventions

Arm Title
S-1 + cisplatin(SP)
Arm Type
Active Comparator
Arm Description
S-1：40~60mg bid，d1~14 q3W cisplatin：60mg/m2，iv drip ，d1,q3W Number of Cycles: until progression or unacceptable toxicity develops.
Arm Title
S-1+Oxaliplatin（SOX）
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
S-1
Intervention Description
S-1：40~60mg bid，d1~14 q3W
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
oxaliplatin：130mg/m2，iv drip for 2h，d1,q3W
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
cisplatin：60mg/m2，iv drip ，d1,q3W
Primary Outcome Measure Information:
Title
Overall Survival
Description
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
Time Frame
1-1.5 year
Secondary Outcome Measure Information:
Title
Objective response rate
Description
The primary endpoint is objective response rate,which equals CR+PR.
Time Frame
1 year
Title
time to treatment failure (TTF)
Description
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.
Time Frame
6 months
Title
progression-free survival (PFS)
Description
The duration is from the randomized time to disease progression or death due to any reason.
Time Frame
6 months
Title
Adverse events (AE)
Time Frame
1-1.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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(+)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ruihua xu, Professor
Organizational Affiliation
SunYat-sen University Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

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

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