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Phase II study of nab-paclitaxel as second-line chemotherapy prior fluoropyrimidine resistance for metastatic or recurrent gastric cancer considering dose reduction on early points

Phase 2
Conditions
gastric cancer
Registration Number
JPRN-UMIN000012247
Lead Sponsor
Chubu Clinical Oncology Group
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up continuing
Sex
All
Target Recruitment
50
Inclusion Criteria

Not provided

Exclusion Criteria

(1) Past history of severe hypersensitivity to drug (2) Severe infectious disease that requires systemic treatment (3) Second primary malignancy except in situ carcinoma or prior malignancy treated within 5 years (4) Serious illness (5) Congestive heart failure, unstable angina or myocardial infarction (6) Much amount of pleural effusion, ascites or cardiac effusion (7) Peripheral nerve disorder (8) Presence of symptomatic or progressing CNS metastasis (9) Psychological illness (10) Pregnant or lactating woman. Women of child bearing potential not using a contraceptive method. Sexually active fertile men not using effective birth control. (11) Any patients judged by the investigator to be unfit to participate in the study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
disease free survival
Secondary Outcome Measures
NameTimeMethod
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