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Phase II study of Bevacizumab with SOX (S-1 plus L-OHP) as second-line therapy in metastatic colorectal cancer

Phase 2
Conditions
Metastatic colorectal cancer
Registration Number
JPRN-UMIN000005199
Lead Sponsor
Tsuchiura kyodo general hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
33
Inclusion Criteria

Not provided

Exclusion Criteria

(1) History of severe allergy (2) Active double cancer (3) Severe infectious disease (4) Peripheral neuropathy (5) Uncontrolled hypertention (6) Sever comorbidity(interstitial lung disease or pulmonary fibrosis, heart failure, renal failure, liver failure, etc) (7) Massive pleural or abdominal effusion (8) Patient with the diarrhea (9) Symptomatic brain metastases (10) Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test (11) Severe mental disorder (12) Systemic administration of corticosteroids (13) Uric protein 2+ (14) Prior radiotherapy for primary and metastases tumors (15) Thrombosis, cerebral infraction, cardiac infraction or pulmonary infraction within 6 months (16) Patients who underwent surgery within 4 weeks (17) Systemic administration of antiplatelet drug (18) Patients with known bleeding disorders or clotting disorder (19) Previous history of adjuvant chemotherapy with L-OHP (20)Any other cases who are regarded as inadequate for study enrollmet by investigators

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Response Rate
Secondary Outcome Measures
NameTimeMethod
Progression Free Survival(PFS) Overall Survival(OS) Safety
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