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A phase II study of trastuzumab added to docetaxel and S-1 for human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer.

Phase 2
Conditions
gastric cancer
Registration Number
JPRN-UMIN000005366
Lead Sponsor
Okayama University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
40
Inclusion Criteria

Not provided

Exclusion Criteria

1) with severe allergy to Trastuzumab, S-1 and docetaxel 2) Active infection or other inflammatory disease 3) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ 4) Other severe complications such as paralytic ileus, intestinal pneumonitis, pulmonary fibrosis, uncontrollable diabetes millutus, hypertension, and respiratory insufficiency. 5) History of cardiac disease 6) Dyspnea at rest, due to complications of advanced malignancy or other cardiovascular disease 7) Metastasis to CNS 8) Grade 3-4 peripheral sensory neuropathy 9) pregnant or nursing patient or with intent to bear baby 10) Inappropriate for the trial at the physician's assessment

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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