A prospective study of investigating the efficacy of FOLFIRI plus Aflibercept as a 2nd line therapy after progression during FOLFOXIRI plus Bevacizumab in unrescetable / metastatic colorectal cancer (CRC) patients. - EFFORT Study

Oki Eiji0 sites35 target enrollmentApril 18, 2019

Overview

No summary available.

Registry

who.int

Start Date

April 18, 2019

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Oki Eiji

•1\)Written informed consent obtained from every patient before enrollment in the study.
•2\)The lead investigator deems that the patient can be treated according to the protocol (the patient is suitable for enrollment).
•3\)Patients with histologically confirmed advanced unresectable colorectal cancer (CRC) or metastatic CRC (mCRC).
•4\)RAS mutation status should be known. If possible BRAF mutation status as well.
•5\)Patients with unresectable CRC or mCRC who received FOLFOXIRI\+bevacizumab as a first\-line therapy. The reason for discontinuation of first line therapy is progressive disease (PD).
•Patients with unresectable CRC or mCRC who discontinued first\-line therapy with FOLFOXIRI\+bevacizumab.
•Patients who underwent adjuvant chemotherapy and FOLFOXIRI\+bevacizumab treatment following recurrence. The date of recurrence confirmation should be at least 6 months from the final day of adjuvant therapy.
•Patients who discontinued 5\-FU/LV\+bevacizumab as a maintenance therapy. FOLFOXIRI\+bevacizumab as induction therapy will be administered for no more than 12 cycles.
•Patients who underwent both induction therapy (FOLFOXIRI\+bevaczizumab) and maintenance therapy (5\-FU/LV\+bevacizumab) are preferable to this study.
•6\)Radiation therapy was not administered to the target lesion.

•1\)Patients with hypertension (\>160 mmHg systolic or \> 100 mmHg diastolic for \>4 weeks) that cannot be adequately controlled with 2 antihypertensive agents\*.
•\*One antihypertensive treatment containing two antihypertensive agents counts as two antihypertensives.
•Patients with diabetes mellitus that cannot be adequately controlled with medication.
•Patients with heart disease that may cause problems, such as congestive heart failure, angina pectoris requiring medication, clear evidence of transmural myocardial infarction on an ECG, clinically evident valvular heart disease, symptomatic coronary disease, poorly controlled arrhythmia, and a previous history of myocardial infarction within the last 12 months..
•2\)Patients with severe pulmonary disease, including interstitial pneumonia, pulmonary fibrosis and severe emphysema.
•3\)Patients with an active infection.
•4\)Patients with clinically significant ascites and pleural effusion.
•5\)Patients who have severe drug hypersensitivity (particularly to 5\-FU, irinotecan, or aflibercept).
•6\)Patients with active multiple cancers. Synchronous double cancer and metachronous double cancer within a disease\-free interval of 5 years. Lesions consistent with carcinoma in situ or intramucosal carcinoma that have been cured by local treatment are not classified as active multiple cancers.
•7\)Patients with a psychiatric disorder that may pose a problem, or a history of central nervous system dysfunction.