Clinical trial NCT01824459: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: 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
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Taiho Pharmaceutical Co., Ltd.
First posted: 2013-04-04
Enrollment: 576
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.

Eligibility 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(+)

Primary outcomes:
measure: Overall Survival
timeFrame: 1-1.5 year
Secondary outcomes:
measure: Objective response rate
timeFrame: 1 year
measure: time to treatment failure (TTF)
timeFrame: 6 months
measure: progression-free survival (PFS)
timeFrame: 6 months
measure: Adverse events (AE)
timeFrame: 1-1.5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: SunYat-sen University Cancer Center
name: ruihua xu, Professor
role: PRINCIPAL_INVESTIGATOR
References: