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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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ClinicalTrials.gov Identifier: NCT01824459
Recruitment Status : Completed
First Posted : April 4, 2013
Last Update Posted : January 23, 2019
Sponsor:
Collaborator:
Taiho Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Ruihua Xu, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: S-1 Drug: Oxaliplatin Drug: Cisplatin Phase 3

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%.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 576 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2013
Actual Primary Completion Date : December 1, 2018
Actual Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: S-1 + cisplatin(SP)
S-1:40~60mg bid,d1~14 q3W cisplatin:60mg/m2,iv drip ,d1,q3W Number of Cycles: until progression or unacceptable toxicity develops.
Drug: S-1
S-1:40~60mg bid,d1~14 q3W

Drug: Cisplatin
cisplatin:60mg/m2,iv drip ,d1,q3W

Experimental: S-1+Oxaliplatin(SOX)
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.
Drug: S-1
S-1:40~60mg bid,d1~14 q3W

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




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 1-1.5 year ]
    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 :
  1. Objective response rate [ Time Frame: 1 year ]
    The primary endpoint is objective response rate,which equals CR+PR.

  2. time to treatment failure (TTF) [ Time Frame: 6 months ]
    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.

  3. progression-free survival (PFS) [ Time Frame: 6 months ]
    The duration is from the randomized time to disease progression or death due to any reason.

  4. Adverse events (AE) [ Time Frame: 1-1.5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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(+)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01824459


Locations
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China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Taiho Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: ruihua xu, Professor SunYat-sen University Cancer Center

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Responsible Party: Ruihua Xu, vice president of SunYat-sen University Cancer Center,head of medical oncology department, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01824459     History of Changes
Other Study ID Numbers: SOX-DGCA
First Posted: April 4, 2013    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019

Keywords provided by Ruihua Xu, Sun Yat-sen University:
Non-intestinal type gastric cancer
Advance Gastric Cancer
Recurrent Gastric Cancer
Gastroesophageal Junction Adenocarcinoma
SOX, S-1+Oxaliplatin
OS,
ORR,
PFS,
TTF,
safety

Additional relevant MeSH terms:
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Adenocarcinoma
Stomach Neoplasms
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Cisplatin
Oxaliplatin
Antineoplastic Agents