A feasibility study of neoadjuvant Oxaliplatin and S-1 for clinical T3 or T4 gastric cancer

A feasibility study of neoadjuvant Oxaliplatin and S-1 for clinical T3 or T4 gastric cancer - A feasibility study of neoadjuvant Oxaliplatin and S-1 for clinical T3 or T4 gastric cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007589

Enrollment

Registered

2012-03-31

Start date

2012-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric cancer

Interventions

Preoperative chemotherapy with Oxaliplatin and S-1 followed by gastrectomy with D2 lymph node dissection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically proven primary gastric adenocarcinoma. 2) Upper GI endoscopy and enhanced abdominal CT revealed having T3 or T4 tumor. 3) Enhanced CT revealed having no distant metastasis. No peritoneal metastasis and CY0 by laparoscopy. 4) Age between 20 and 75 at registration. 5) Performance Status(ECOG) 0 or 1. 6) No prior treatment of chemotherapy nor radiation therapy nor endocrine therapy against any other malignancies. No prior surgery for gastric carcinoma. 7) No bleeding from primary lesions nor obstruction. 8) Fair oral intake with or without bypass surgery. 9) CT revealed no interstitial pneumonia, pulmonary fibrosis, nor severe emphysema. 10) Adequate organ functions defined as indicated below; i) WBC >= 3,000/mm3 and <=12,000/mm3. ii) Hb >= 9.0 g/dL. iii) Platelet >= 100,000/mm3. iv) AST <= 50 IU/L. v) ALT <= 50 IU/L. vi) T.Bil <= 1.5 mg/dL. vii) Creatinin <= 1.2 mg/dL . viii) CCr >= 60mL/min/body 11) Written informed consent from patient.

Exclusion criteria

Exclusion criteria: 1)Enhanced abdominal CT revealed no Bulky lymph node (>=3cmx1 or >=1.5cmx2). 2)No coagulation disorder. 3)Body temperature >=38 centigrade at the time of enrollment. 4) Active bacterial or fungal infection. 5) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema. 6) History of hypersensitivity to L-OHP, Fluorouracil, Tegafur, Gimeracil, Oteracilo Potassium, Dexamethason,or 5-HT3 receptor antagonist. 7) Peripheral motor neuropathy or peripheral sensory neuropathy by any reason. 8) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal cancer. 9) Under treatment with flucytosine, phenytoin, or warfarin. 10) Women during pregnancy or breast-feeding. 11) Severe mental disease. 12) Under treatment with systemic steroid. 13) Uncontrollable diabetes mellitus or routine administration of insulin. 14) Uncontrollable hypertension. 15) Active gastrointestinal bleeding. 16) Past history of myocardial infarction or unstable angina pectoris within 6 months. 17) HBs antigen positive.

Design outcomes

Primary

Measure	Time frame
proportion of protocol completion	—

Secondary

Measure	Time frame
overall survival, relapse-free survival,response rate, pathological response rate,adverse events, operative morbidity, treatment related death	—

Countries

Japan

Contacts

Public ContactYoshitaka Honma

National Cancer Center Hospital Gastrointestinal Oncology Division

03-3542-2511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026