Phase II study to examine efficacy prediction of Regorafenib with FDG-PET/CT in patients with treatment-refractory metastatic colorectal cancer
- Conditions
- Colorectal Cancer
- Registration Number
- JPRN-UMIN000015563
- Lead Sponsor
- onprofit Organization Japan Clinical Cancer Research Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 20
Not provided
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method (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