A phase II trial of TS-1/CDDP as neoadjuvant chemotherapy against resectable gastric cancer.

A phase II trial of TS-1/CDDP as neoadjuvant chemotherapy against resectable gastric cancer. - A phase II trial of TS-1/CDDP as neoadjuvant chemotherapy against resectable gastric cancer.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004466

Enrollment

110

Registered

2010-10-28

Start date

2010-03-01

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

TS-1: Day1-21, p.o. and CDDP: Day8. 1 course takes 35 days. 1 course TS-1: Day1-21, p.o. and CDDP: Day8. 1 course takes 35 days. 2 courses

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Primary gastric adenocarcinoma 2.The pathological material of the gastric carcinoma before chemotherapy 3.M (-),H (-),c-StageIII and IV in the staging classification 4.Adjustment of Neoadjuvant chemotherapy with TS-1+CDDP 5.Measurable lesions according to RECIST guidelines 6.No history of pretreatment (radiotherapy, chemotherapy,etc.) except surgery 7.PS(ECOG) is 0-2 8.Adequate organ function WBC>=4000/mm3 Neutrophil count>=2,000/mm3 Platelet count>=100,000/mm3 Hemoglobin>=8.0 g/dL 9.Liver function tests AST (GOT) and ALT (GPT) <=100IU/L Total bilirubin<=2.0 mg/dL 10.Renal function test CCr(e-GFR)>=60ml/min Serum creatinine<=1.50 mg/dL 11.Age 20 to 80 years old 12.With written informed consent

Exclusion criteria

Exclusion criteria: 1.Metachronous or synchronous multiple cancer 2.Pregnant or in lactation. 3.Patient who is judged to be inappropriate as subject to this study by the principal investigator or the doctors in charge.

Design outcomes

Primary

Measure	Time frame
The effect of the tumor reduction of providing by the chemotherapy effect judgment standard is used. The doctor in charge judges the effect of the tumor reduction based on RECIST(http://www.recist.com/recist-in-practice/22.html) version 1.1.	—

Countries

Japan

Contacts

Public ContactHideaki Shimada

Toho University School of Medicine Division of general and Gastroenterological Surgery,Department of Surgery(Omori)

hideaki.shimada@med.toho-u.ac.jp03-3762-4151

Outcome results

None listed

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