Randomized Phase II study of Bevacizumab with SOX versus Bevacizumab with XELOX as second-line therapy in metastatic colorectal cancer which has prior therapy of S-1 and CPT-11
- Conditions
- Metastatic colorectal cancer
- Registration Number
- JPRN-UMIN000006911
- Lead Sponsor
- Tsuchiura kyodo general hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Not provided
(1) History of severe allergy (2) Pregnant or lactating women or women of childbearing potential (3) Severe infectious disease (4) Serious complication (e.g. interstitial pneumonia or pulmonary fibrosis, kidney injury, hepatic failure, uncontrolled diabetes mellitus, uncontrolled hypertension) (5) Comorbidity or history of heart failure (6) Peptic ulcers (7) Peripheral neuropathy (8) Severe diarrhea (9) Massive ascites or pleural effusion requiring treatment (10) Metastasis to the CNS (11) Current or previous (within the last 6 months) history of GI perforation (12) Previous history of thromboembolism, cerebral infarction, pulmonary infarction, interstitial pneumonia or hemoptysis (=> 2.5ml) (13) Any surgical treatments within 28 days (14) Evidence of bleeding diathesis or coagulopathy (15) Ongoing treatment with anticoagulant or aspirin (> 325mg/day) (16) Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ (17) Under coutinuous steroid administration (18) Administration contraindication of L-OHP, Bevacizumab, S-1 or Capecitabine (19) Presence of severe colorectal stricture (20) Any other cases who are regarded as inadequate for study enrollment by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS)
- Secondary Outcome Measures
Name Time Method Response rate (RR) Time to treatment failure (TTF) Overall Survival (OS) Safety profile