Phase II study of first-line treatment by FOLFOXIRI+bevacizumab in patients with RAS mutant-type metastatic colorectal cancer
- Conditions
- Colorectal Cancer
- Registration Number
- JPRN-UMIN000015152
- Lead Sponsor
- onprofit Organization Japan Clinical Cancer Research Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Not provided
(1) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval. (2) Brain metastases. (3) Infectious disease. (4) Interstitial lung disease or pulmonary fibrosis. (5) Comorbidity or history of serious heart failure. (6) History of thromboembolic events. (7) Cerebrovascular disease. (8) History of hemoptysis/hematemesis. (9) Uncontrolled hypertension.(systolic BP>180mmHg, or diastolic BP>100mmHg) (10) Sensory alteration or paresthesia interfering with function. (11) Large quantity of pleural, abdominal or cardiac effusion. (12) Severe comorbidity (renal failure, liver failure, hypertension, etc) (13) Prior radiotherapy for primary and metastases leision. (14) Men/women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test. (15) History of severe allergy. (16) HBs-Ag(+), or HCV-Ab(+). (17) Administration of blood products/ G-CSF, and blood transfusion within 14 days. (18) Surgical procedure or such as skin-open biopy, trauma surgery, or other more intensive surgeries within 28 days. (19) Systemaic administration of antiplatelet drug or NSAIDs. (20) Diathesis of bleeding (history of hemoptysis, including cavitation and/or necrosis in lung metastasis confirmed by imaging), coagulopathy. (21) Active peptic ulcer. (22) History of gastrointestinal perforation within 1 year. (23) Unhealed traumatic bone fracture. (24) Uncontrolled diarrhea. (25) History of organ recipient . (26) Prior bevacizumab/Irinotecan/Oxaliplatin treatment.(Adjuvant therapy by Oxaliplatin is excluded) (27) Administration of atazanavir sulfate. (28) Jaundice. (29) Ileus or bowel obstruction. (30) Any other cases who are regarded as inadequate for study enrollment by investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response Rate
- Secondary Outcome Measures
Name Time Method Progression free survival Overall Survival Safety Early Tumor Shrinkage Deepness of Response Correlation between biomarkers and therapeutic effects and prognosis