jRCTs031180130CompletedNot Applicable
Phase II study of primary treatment by FOLFOXIRI+bevacizumab in patients with RAS mutant-type metastatic colorectal cancer (JACCRO CC-11 )
Not provided0 sites60 target enrollmentStarted: February 18, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 60
- Primary Endpoint
- -
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Single Arm Study
- Intervention Model
- Single Assignment
- Primary Purpose
- Treatment Purpose
- Masking
- Open(masking Not Used)
Eligibility Criteria
- Ages
- 20age old over to 76age old not (—)
- Sex
- All
Inclusion Criteria
- •(1) Histologically confirmed colorectal cancer. (2) KRAS mutant-type, or RAS mutant-type. (3) Measurable leision by RECIST(Ver.1.1) (4) No past history of chemotherapy in the case of unresectable primary lesion/distant metastasis/lymph node metastasis.In the case of recurrence, no treatment for the first recurrence leision after operation. (5) Age; more than 20 years old, under 76 years old. (6) ECOG Performance status 0-1.The case >=71 years is PS
- •(7) Life expectancy of more than 3 months. (8) Patiens have enough organ function for study treatment within 14 days before enrollment; 1) WBC>=3,000/mm3, <12,000/mm
- •Neu>=1,500/mm
- •PLT>=10.0x104/mm
- •Hb>=9.0g/dL. 5) Total Bilirubin<=1.5xULN. 6) AST<=2.5xULN. 7) ALT<=2.5xULN. 8) Creatinine<=1.5xULN. 9) Proteinuria<=1+. 10) PT-INR<=1.
- •(9) Written informed consent.
Exclusion Criteria
- •(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.
Outcomes
Primary Outcomes
-
Response Rate
Secondary Outcomes
No secondary outcomes reported
Investigators
Similar Trials
Recruiting
Not Applicable
JBCRG-C11(CREA)HER2-positive advanced or metastatic breast cancerjRCT1031240010DAIICHI SANKYO COMPANY, LIMITED100
Active, not recruiting
Not Applicable
C-PROWESS study (C-PROWESS study)Neo Ras Wild type metastatic colorectal cancerjRCTs03121056530
Recruiting
Not Applicable
ACE study (ACE study)Gastric adenoma or early gastric cancer that is an absolute indication for ESD.jRCT103224050764
Completed
Not Applicable
Lucent-J Study (Lucent-J Study)Type 2 diabetes mellitusjRCTs05122001640
Recruiting
Not Applicable
JBCRG-M10 (INDUCE trial)PD-L1-positive, hormone receptor-negative, HER2-negative inoperable or recurrent breast cancerjRCTs041240039106