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Phase II clinical trial of surgical intervention following chemotherapy for synchronous and metachronous liver metastasis from gastric cancer.

Phase 2
Recruiting
Conditions
Patients with synchronous or metachronous liver metastasis from gastric cancer
Registration Number
JPRN-UMIN000011445
Lead Sponsor
Department of Surgery, Osaka University Graduate School of Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
50
Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with difficulty in oral intake. 2) Patients with contraindication for administration of S-1, Cisplatin, Docetaxel, Capecitabine, Trastuzumab, and 5 FU. 3)Patients with other kinds of active cancers overlapping gastric cancer. 4) Patients with evidence of peritoneal dissemination or metastatic lesion other than liver (eg. bone, brain). 5) Patients with a history of bone metastasis.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Three years overall survival rate of patient who achieved curative treatment.
Secondary Outcome Measures
NameTimeMethod
Rate of complete resction (surgical resection), and rate of curative treatment (include intervention of RFA or MCT) for hepatic lesion. Safety of procedure (rate of intra/post operative adverse events), recurrence-free survival time of curative treatment case, and overall survival time of registered patients.
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