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A Phase II study of induction chemotherapy with docetaxel, S-1 and cisplatin (DCS) for advanced gastric cancer with peritoneal metastasis (KUGC06)

Not Applicable
Conditions
Gastric cancer with peritoneal metastasis
Registration Number
JPRN-UMIN000004932
Lead Sponsor
Department of Surgery Graduate School of Medicine, Kyoto University
Brief Summary

Among 30 enrolled patients, 24 completed three cycles of DCS. The most frequent grade 3 or 4 toxicity was neutropenia (60%). A complete response of peritoneal metastasis was observed in 16 patients, and 14 patients achieved R0 resection (47%; 95% confidence interval 28to66%). When the extent of peritoneal metastasis was classified as P0CY1, P1, P2, and P3 according to the Japanese classification, the R0 resection rates were respectively 63%, 60%, 46% and 0%.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
30
Inclusion Criteria

Not provided

Exclusion Criteria

1)Active bleeding from the tumor 2)Paralysis of intestine or ileus 3)Diarrhea(watery stool) 4)Synchronous multicancer 5)Serous infection 6)Interstitial pneumonitis or fibroid lung 7)Ascites requiring control or peritoneal metastasis detected by CT 8)Uncontrollable diabetes mellitus 9)Uncontrollable hypertention, heart insufficiency, myocardial infarction within 6 months,uncontrolled arrhythmia or angina 10)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 11)Patient who has experienced serious drug allergy in the past 12)Patient with severe phyciatric disease 13)Patient who requires continuous use of flucytosine, phenytoin 14)HBsAb positive 15)Patient who is judged to be inappropriate as subject to this study by the principal investigator or the doctors in charge

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
R0 resection ratio
Secondary Outcome Measures
NameTimeMethod
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