Colorectal Cancer
Conditions
Interventions
Regorafenib:160 mg orally, once daily for 3 weeks and one week rest in each cycle.
Sponsors
Nonprofit Organization Japan Clinical Cancer Research Organization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histologically confirmed colorectal cancer. (2) Metastatic or inoperable locally advanced colorectal cancer(regardless RAS mutation). (3) Measurable lesion by RECIST (Ver.1.1). (4) Evaluable target lesion by FDG-PET/CT. (5) Refractory to fluoronated pyrimidine, oxaliplatin, Irinotecan, bevacizumab, and anti-EGFR antibody therapy. (6) ECOG Performance status 0-1. (7) Age>=20 years old. (8) Life expectancy of more than 3 months. (9) Able to take oral medications. (10)Patients 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>= 100,000/mm3. 4) Hb>= 9.0g/dL. 5) Total bilirubin<= 1.5x ULN. 6) AST<= 2.5x ULN. 7) ALT<= 2.5x ULN. 8) Creatinine<= 1.5x ULN. 9) PT-INR<= 1.5x ULN. (11) Written informed consent.
Exclusion criteria
Exclusion criteria: (1) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years of disease free survival. (2) Serious infection. (3) Following severe comorbidity. 1) Diabetes mellitus required insulin. 2) Uncontrolled hypertension(systolic BP>150mmHg, and/or diastolic BP>90mmHg). 3) Unstable angina,Myocardial infarction,Cerebral infarction,Pulmonary embolism within 6months. 4) Abnormal cardiac rhythm required anti arrhythmic agent. 5) Congestive heart failure(NYHA>=class2). 6) Active or chronic hepatitis B and/or hepatitis C. 7) Active interstitial pneumonia. 8) Hemorrhages(CTCAE>=Grade3) within 4 weeks prior to enrollment. 9) Non-healing wound, ulcer, or bone fracture. (4) Brain metastases. (5) History of treatment by Regorafenib. (6) History of allergy with Regorafenib. (7) Extended field radiotherapy within 4 weeks or local radiotherapy within 2 weeks prior to enrollment. (8) Major surgery, skin-open biopy, severe injury within 4 weeks prior to enrollment. (9) Sustained proteinuria(3+) (10) Men/women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test. (11) Any other cases who are regarded as inadequate for study enrollment by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate in change of SUVmax in primary target lesion (the highest value in SUVmax at baseline) at 4 weeks after treatment by Regorafenib. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Response rate in change of SUVmax in target lesion (up to 5 lesions) at 4 weeks after treatment by Regorafenib. (2) Progression free survival (3) Overall Survival (4) Response Rate (5) Disease control rate (6) Relationship between change of SUVmax and OS,PFS (7) AE | — |
Countries
Japan
Contacts
Public ContactFujii Masashi
Nonprofit Organization Japan Clinical Cancer Research Organization Office
Outcome results
None listed