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A Phase I study of induction chemotherapy with S-1 and Cisplatin plus intraperitoneal administration of Docetaxel for gastric cancer with peritoneal dissemination

A Phase I study of induction chemotherapy with S-1 and Cisplatin plus intraperitoneal administration of Docetaxel for gastric cancer with peritoneal dissemination - A Phase I study of intraperitoneal Docetaxcel with S-1 and Cisplatin for gastric cancer with peritoneal dissemination (KUGC05)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002524
Enrollment
15
Registered
2010-01-01
Start date
2011-01-01
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

Chemotherapy

Sponsors

Department of Surgery Graduate School of Medicine, Kyoto University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Histological diagnosis of gastric adenocarcinoma 2) Laparoscopy revealed macro- or microscopic peritoneal dissemination as the only factor for Stage IV 3) Distant metastasis was excluded by image diagnosis 4) No prior therapy for gastric cancer 5) Performance Status (ECOG):0-1 6) Oral intake of S-1 is possible 7) Written informed consent 8) Biology and biochemistry within normal limits

Exclusion criteria

Exclusion criteria: 1)Active bleeding from the tumor 2)Paralysis of intestine or ileus 3)Diarrhea(watery stool) 4)Synchronous multicancer 5)Pleural effusion or ascites requiring control 6)Serious comorbidity including -Serious infection -Uncontrollable diabetes mellitus -Heart failure requireing control -Uncontrolled arrhythmia or angina -Severe phyciatric disease -Interstitial pneumonitis or fibroid lung 7)Myocardial infarction within 6 months 8)Patient who has experienced serious allergy for any drug or polysorbate 80 in the past 9)Patient who is pregnant or in lactation, or wish to become pregnant during this study.Male patient who intends to make someone pregnant during this study 10)Patient who requires continuous use of flucytosine 11)Patient who is judged to be inappropriate as subject to this study by the principal investigator or the doctors in charge

Design outcomes

Primary

MeasureTime frame
To determine the maximum tolerated dose and the recommended dose

Countries

Japan

Contacts

Public ContactHiroshi Okabe

Graduate School of Medicine, Kyoto University Department of Surgery

hokabe@kuhp.kyoto-u.ac.jp

Outcome results

None listed

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