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The investigators propose a phase II clinical trial with the objective to investigate the potential clinical interest to associate regorafenib with a metronomic chemotherapy combining capecitabine, cyclophosphamide and low-dose aspirin, for the treatment of patients with metastatic colorectal cancer. The main objective of the study will be to achieve 15% of objective response rate in patients treated with multimodal metronomic chemotherapy and regorafenib.
Enrollment
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Inclusion criteria
Patients with histologically proven metastatic colorectal cancer in progression after previous standard treatments (5FU, CPT11, oxaliplatin, anti-VEGF and anti-EGFR therapy if KRAS and NRAS WT), or not considered as candidate for these treatments
Life expectancy of at least 3 months
Female or male with age >18 years old
Performance status = 0 or 1 (Annex 1)
Measurable disease defined according to RECIST v1.1 (scanner or MRI) (Annex 2)
Adequate bone marrow, liver and renal functions.
Imaging target greater than one cm must be visible on CT,
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. 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
49 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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