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This study evaluates the interest of regorafenib in combination of metronomic chemotherapies and low-dose aspirin as a 2 months induction therapy before chemotherapy initiation in the second-line metastatic colorectal carcinoma
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Inclusion criteria
Patients with histologically proven metastatic colorectal cancer in progression after a first line of chemotherapy +/- targeted therapy
Patients must have been treated for their metastatic disease with one of the following regimens as first-line therapy:
Of note, a chemotherapy prescribed for metastases occurring within six months after the end of an adjuvant chemotherapy are considered as a second line of therapy.
Patients should have a history of resistance to first line chemotherapy defined by:
Life expectancy of at least 3 months
Female or male with age ≥18 years old
Performance status Eastern Cooperative Oncology Group World Health Organization (ECOG-WHO) ≤1 (Appendix 1),
Measurable disease defined according to RECIST v1.1 (scanner or MRI)
Molecular status: patients eligible should have microsatellite-stable (MSS) status, absence of BRAF V600E (B(Raf gene, val600-to-glu) mutation and a known RAS (Retrovirus Associated Sequences) status.
Adequate bone marrow, liver and renal functions.
No contraindication to Iodine contrast media injection during CT
For female patients of childbearing potential, negative pregnancy test within 14 days before starting the study drug through at 210 days after the last dose of regorafenib. Men and women are required to use adequate birth control during the study (when applicable),
Signed and dated informed consent,
Ability to comply with the study protocol, in the Investigator's judgment.
Registration in a national health care system (CMU included).
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
446 participants in 2 patient groups
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Central trial contact
Angélique VIENOT, MD, PhD; Christophe BORG, MD, PhD
Data sourced from clinicaltrials.gov
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