JACCRO CC-11 study

Phase 2

• Conditions: Colorectal cancer

• Registration Number: JPRN-jRCTs031180130
• Lead Sponsor: Sekikawa Takashi

Brief Summary

Modified FOLFOXIRI plus bevacizumab regimen consisted of reduced dose of irinotecan and 5FU compared to dose of the TRIBE study. Primary endpoint of response rate was almost same as one of the TRIBE trial. The incidence of febrile neutropenia was 4.8%. Considering this, modified-FOLFOXIRI plus bevacizumab regimen is feasible and very effective regimen for Japanese patients.

Detailed Description

Not available

Study Timeline

• Results First Posted: 2018-03-06
• Study Start: 2019-02-18
• Study Completion: 2019-10-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 64

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 PS0. (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/mm3. 2) Neu>=1,500/mm3. 3) PLT>=10.0x104/mm3. 4) 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<=1.5. (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.

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<br>Overall Survival<br>Safety<br>Early Tumor Shrinkage<br>Deepness of Response<br>Correlation between biomarkers and therapeutic efects/prognosis