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Phase III, Randomized, Multicenter, Controlled Evaluation of S‐1 and Oxaliplatin as Neoadjuvant Chemotherapy for Advanced Gastric Cancer Patients

Phase 3
20 Years
75 Years
Open (Enrolling)
Gastric Adenocarcinoma

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Trial Information

Phase III, Randomized, Multicenter, Controlled Evaluation of S‐1 and Oxaliplatin as Neoadjuvant Chemotherapy for Advanced Gastric Cancer Patients

Inclusion Criteria:

1. Histologically confirmed gastric adenocarcinoma

2. Gastroesophageal junction tumour type II or III(NCCN 2009) can be enrolled

3. All patients must undergo EUS,CT(or PET-CT) and laparoscopy to evaluate tumor stage
classification (TNM), and only stage II or III (AJCC 7th) gastric cancer patients can
be enrolled

4. planning to undergo gastric cancer D2 surgery after neoadjuvant chemotherapy

5. KPS > 60; ECOG performance status 0-2

6. Life expectancy > 6 months

7. Age: 20 to 75 years

8. No other severe disease and life expectancy less than five years

9. 7 days before enrolled, baseline data should be finished including:

- Granulocyte count ≥ 1.5×109/L;

- platelet count ≥ 100×109/L;

- Hemoglobin ≥ 90g/L;

- hepatic < 1.5×ULN;

- total bilirubin ≤ 1.0×ULN;

- creatinine < 1.5×ULN;

- PT-INR/PTT < 1.7× ULN

10. Disease had to be measurable by the Response Evaluation Criteria in Solid Tumors
(RECIST1.1) criteria

11. Written informed consent and able to comply with the protocol

Exclusion Criteria:

1. Patient cannot undergo surgery or chemotherapy because of other severe disease

2. Be allergic to chemotherapy drugs

3. Patients receiving any chemotherapy or drugs involved in this trial in four weeks
before enrolled

4. Patients received cytotoxic chemotherapy, targeted therapy, immunotherapy or
radiotherapy for gastric cancer

5. Within the last 5 years in patients with a history of other malignant diseases

6. Pregnant or breast-feeding women

7. Severe heart disease like symptoms of coronary heart disease, New York Heart
Association (NYHA) grade II or worse congestive heart failure or cardiac arrhythmia
having medications or myocardial infarction within the last 12 months

8. Patients with upper gastrointestinal obstruction or absorption anomaly; patient in
obstruction of the Helicobacter pylori failure like effect S-1 to take and absorb

9. Patients with a history of peripheral nerve disease

10. Patients who get organ transplant

11. lack of dihydropyrimidine dehydrogenase (DPD)

12. Infection or other disease failure to control

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

disease free survival

Outcome Description:

SOX regimen as Neoadjuvant chemotherapy for AJCC II-III gastric cancer patients is superior than postoperative SOX after D2 surgery.Disease free survival is defined as time of surgery to recurrence or death.

Outcome Time Frame:

three years

Safety Issue:



China: Food and Drug Administration

Study ID:




Start Date:

March 2012

Completion Date:

January 2017

Related Keywords:

  • Gastric Adenocarcinoma
  • two arms
  • D2 lymphadenectomy
  • chemotherapy before and after surgery
  • disease free survival
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms