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A Phase II trial of neoadjuvant chemotherapy with S-1 and fractional cisplatin for locally advanced gastric cancer

A Phase II trial of neoadjuvant chemotherapy with S-1 and fractional cisplatin for locally advanced gastric cancer - A Phase II trial of neoadjuvant chemotherapy with S-1 and fractional cisplatin for locally advanced gastric cancer

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001777
Enrollment
25
Registered
2009-03-16
Start date
2007-05-01
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

Sponsors

Division of Biological Regulation and Oncology, Department of Surgery, Graduate School of Medicine, Tohoku University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Selection Criteria 1)Pathologically confirmed gastric cancer 2) i)cStageIIIa or IIIb ii)Borrmann Type III with the maximum tumor diameter of 8cm or more iii)Borrmann Type IV 3) a case with clinically resectable legion 4) a case with target lesion or measurable lesion 5) No previous treatment 6) Age between 20 and 75 years old when an informed concent was taken. 7) ECOG 0 or 1 Informed concent 8)Biology and biochemistry data are fit for the following criteria within 14 days before registration. a) WBC ≥ 3,500/µL b) PLT ≥ 100,000/µL c) Hb ≥ 9.0 g/dL d) AST, ALT ≤ ULN x 2.0 e) T-Bil ≤ ULN x 2.0 f) CRE ≤ ULN or CCR ≥ 50ml/min 9) Patient who can eat orally and is judged to be appropriate for neoadjuvant chemotherapy by the principal investigator 10) written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: Exclusion criteria 1)Fresh bleeding from the tumor 2)Paralysis of intestine or ileus 3)Diarrhea(watery stool) 4) Synchronous multicancer 5) infection 6) Interstitial pneumonitis or fibroid lung 7) a large amount of pleural effusion or ascites 8) Jaundice 9)Uncontrollable diabetes mellitus, 10) heart failure requiring the treatment, myocardial infarction within 6 months, uncontrolled arrhythmia or angina 11)Patients pregnant or in lactation, or wish to become pregnant during this study. Male patients who intend to make someone pregnant during this study 12)Patient who has experienced serious drug allergy in the past 13)Patient who is judged to be inappropriate for this study by the principal investigator or the doctors in charge

Design outcomes

Primary

MeasureTime frame
Response rate, pathological response

Secondary

MeasureTime frame
Over all survival , relapse free survival, curative resection rate, operative complication rate, adverse event

Countries

Japan

Contacts

Public ContactMakoto Kinouchi

Graduate School of Medicine, Tohoku University Division of Biological Regulation and Oncology, Department of Surgery

kinouchi@surg1.med.tohoku.ac.jp022-717-7205

Outcome results

None listed

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