Feasibility stuydy of S-1 and weekly cisplatin in patients received R0 resection for Stage IIB and III gastric cancer

Feasibility stuydy of S-1 and weekly cisplatin in patients received R0 resection for Stage IIB and III gastric cancer - Feasibility study of S-1 and weekly cisplatin in patients recieved R0 resection gastric cancer.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005600

Enrollment

Registered

2011-05-15

Start date

2011-05-01

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

At the first course of adjuvant chemotherapy, only S-1 is administered for 28 days followed by 14 days rest. At the 2 - 4 course, S-1 plus CDDP adjuvant chemotherapy is conducted. After 5 course,

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically proved adenocarcinoma of stmach 2) >= D2 lymphnode dissection, curability A(R0) 3) Stage IIB/III/IIIB/IIIC (Japanese classification) 4) Age between 20 and 75 5) No prior chemotherapy or radiotherapy 6) Able to started of treatment between 8 weeks after surgery 7) ECOG performance status 0-1 8) With ability of oral intake 9) Patients have enough organ function for study treatment Hemoglobin >9.0g.dl WBC 3,500/mm3< <12,000/mm3 Neutrophil > 2,000/mm3 Platelets >100,000/mm3 Total bilirubin <1.5mg/dl AST and ALT < 100IU Ccr > 60ml/min 10) Written informed consent

Exclusion criteria

Exclusion criteria: 1) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ 2) administration contraindication to S-1 and CDDP 3) systemic administration of corticosteroids, flucytosine, phenytoin or warfarin 4) with active infection 5) with drug hypersensitivity 6) other severe complications, such as paralytic ileus, bowel obstruction, interstitial pneumonitis, pulmonary fibrosis, regular use of insulin or uncontrollable diabetes mellitus, arrhythmias, heart failure, liver cirrhosis, and active hepatitis) 7) with water solubility diarrhea 8) pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant 9) men with willing to get pregnant 10)Any other cases who are regarded as inadequate for study enrollment by the investigator

Design outcomes

Primary

Measure	Time frame
Treatment compliance with proportion of patients receiving 4 courses of Adjuvant treatment according to protocol	—

Secondary

Measure	Time frame
Adverse Event, Overall survival, Disease-free survival, and Relapse-free survival	—

Countries

Japan

Contacts

Public ContactManabu Otha

Hamamatsu University School of Medicine Hamamatsu University School of Medicine

otam@hama-med.ac.jp053-435-2279

Outcome results

None listed

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