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Phase Ⅱ Study of S-1 Combined With Oxaliplatin (SOX)Verse S-1 Combined With Cisplatin(SP) in Adjuvant Chemotherapy After D2 Surgery

Phase 2
18 Years
Open (Enrolling)
Gastric Cancer

Thank you

Trial Information

Phase Ⅱ Study of S-1 Combined With Oxaliplatin (SOX)Verse S-1 Combined With Cisplatin(SP) in Adjuvant Chemotherapy After D2 Surgery

Inclusion Criteria:

- histologically confirmed Phase III adenocarcinoma of gastric and esophageal-gastric
junction ( AJCC 7th)

- without previous treatment, including radiotherapy, chemotherapy and immunotherapy

- Hb≥90g/L,WBC 4×109/L-10×109/L,ANC≥2×109/L,Platelet≥100×109/L

- creatinine≤1 UNL

- total bilirubin≤1.5 UNL,AST(SGOT),ALT(SGPT) and ALP≤2.5 UNL

- ECOG score 0 - 2

- take chemotherapy for 8 weeks after surgery

- older than 18 years

- can be followed up, good compliance

- can take medicine orally

- having signed informed consent

Exclusion Criteria:

- combined disease lead to Life Expectancy less than 3 years

- any evidence to show metastasis,including cancer cells in peritoneal fluid

- inability to take oral medication for difficult to swallow, intestinal
obstruction,active intestinal blooding or perforation

- previous treatment,including cytotoxic chemotherapy, radio chemotherapy or
immunotherapy ( except corticosteroid hormone)

- operation within 4 weeks, or not recovered from last major operation

- allergy with fluorouracil

- allergy with Platinum or any composition in research drugs

- uncontrollable seizure disorder,central nervous system disease or mental disorders,
and has clinical significance by judgement of researchers, or can influnce
understanding of informed consent or compliance to take orally drugs

- in the past 12 months, has clinical significant heart disease(active),such as
symptomatic coronary heart disease, > =Stage II congestive cardiac failure;congestive
heart failure as NYHA standard, or serious arrhythmias need take medicine( as
Appendix 10th),or myocardical infarction.

- pregnancy, lactation, women in child-bearing period and her spouses reject to take
effictive method to conraception

- other previous malignancy within 5 years, except healed skin basal cell carcinoma and
carcinoma in cervix

- peripheral neuropathy> grade 1 of CTCAEv3, except the neural abnormality patients who
only lose deep tendon reflex(DTRs).

- serious complicated infection or other complicated diseases and hard to controll.

- As one of belowing:

- ANC < 2×109/L

- Platelet<100×109/L

- total bilirubin>1.5 UNL

- ALAT、ASAT > 2.5 x ULN

- ALP> 2.5 x ULN

- Any investigational agent within the past 28 days. That is the patient had jioned
another trial.

Type of Study:


Study Design:

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

Outcome Measure:

replase free survival

Outcome Time Frame:

3 months

Safety Issue:



China: Food and Drug Administration

Study ID:




Start Date:

April 2011

Completion Date:

June 2018

Related Keywords:

  • Gastric Cancer
  • Gastric cancer
  • D2 surgery
  • S-1
  • Oxaliplatin
  • cisplatin
  • Stomach Neoplasms