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A feasibility study of adjuvant S-1+CDDP for stage III gastric cancer

A feasibility study of adjuvant S-1+CDDP for stage III gastric cancer - Adjuvant S-1+CDDP for stage III gastric cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013479
Enrollment
30
Registered
2014-03-24
Start date
2014-03-24
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

Stage III (the 14th edition of staging system of Japanese Classification of Gastric Carcinoma) gastric cancer based on pathological findings after curative resection.

Interventions

Sponsors

Department of Medical Oncology, Toranomon Hospitalnasoi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with histologically proved adenocarcinoma of advanced gastric cancer and esophagogastric junction. 2) Patients after curative resection of gastric cancer, and was diagnosed stage III (14th staging system of Japanese Gastric Cancer Association). 3) Age: 20-75. 4) ECOG performance status 0-1. 5) Patients with adequate bone marrow reserve (neutrophil count >=1500/mm3, hemoglobin level >= 8.0 g/dL, platelet count >= 100,000/mm3), adequate liver function (AST and ALT <= 100 IU/L, total bilirubin <= 1.5 mg/dL), kidney function (serum creatinine <=1.5 mg/dL). 6) Patients who can intake orally. 7) Written informed consent obtained from patients.

Exclusion criteria

Exclusion criteria: 1) Patients who received surgery within 2 weeks before enrollment. 2) Patients with uncontrable diabetis. 3) Patients who has past history of myocardial infarction within 6 months before enrollment or who has unstable angina. 4) Patients who receive anti-arrhythmia drug (except warfarin for atrial fibrillation). 5) Patients with liver chirrosis. 6) Patients with severe renal failure. 7) Patients with ileus or subileus. 8) Patients who receive continuous corticosteroid administration. 9) Patients with active infections. 10) Patients with uncontrollable ascites, pleural effusion or pericardial effusion. 11) Patients with a history of serious drug allergy. 12) Patients with grade 2-4 diarrhea based on CTCAE ver 4. 13) Patients with interstitial pneumonia or pulmonary fibrosis detected by chest X-ray. Pregnant or lactating female. 14) Patients with grade 2-4 neuropathy based on CTCAE ver 4. 15) Patients who recieved transfusion within 2 weeks before enrollment, or has active bleeding. 16) Pregnant or lactating female. 17) Other patients evaluated to be inadequate to participate in this study by investigators.

Design outcomes

Primary

MeasureTime frame
The proportion of accomplishing three cycles S-1+CDDP therapy

Countries

Japan

Contacts

Public ContactKoichi Suyama

Toranomon Hospital Department of Medical Oncology

kou_susan@yahoo.co.jp0335881111

Outcome results

None listed

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