ONCOGRAM: study protocol for the evaluation of therapeutic response and survival of metastatic colorectal cancer patients treated according to the guidelines of a chemosensitivity assay, the Oncogramme®

Table 1 Overview of patient management steps during the whole course of the ONCOGRAM trial

Patient management step	Pre-inclusion day − 30 to day − 1	Inclusion day 0	Before first chemotherapy treatment	Follow-up visits	Final follow-up visit day 0 + 12 months
Information given to patient	✓
Check eligibility criteria	✓	✓
Obtain patient's informed consent		✓
Randomization		✓
Clinical examination^a		✓		✓	✓
Biological examination	✓^b	✓^b		✓^b	✓^b
Paraclinical examination^c		✓		✓	✓
EQ5D-5 L questionnaires		✓^d	✓^d	✓^d	✓^d
Search for adverse effects of chemotherapies				✓	✓

^aClinical examination: weight, height, cardiopulmonary checkup, comorbidities assessment, WHO performance status
^bAlbumin, protides, CEA, CA 19-9, complete blood count, liver function test (creatinine, AST, ALT, alkaline phosphatase, bilirubin, GGT): compulsory for inclusion and at months 1, 3, 6, 9 and 12. A urinary/blood pregnancy test is also performed for women of procreating age before inclusion
^cParaclinical examination includes if needed colonoscopy, MRI, PET scan, abdominal ultrasonography, thoraco-abdominopelvic CT
^dEQ5D-5 L questionnaires are filled by the patient before first chemotherapy, then at months 3, 6, 9 and 12

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