Predictive Value of Drug Sensitivity Testing Tumorspheres From Patients With Metastatic Colorectal Cancer

Inclusion criteria

• Metastatic colorectal cancer

• Biopsy proven adenocarcinoma compatible with colorectal origin (primary tumor or metastasis)
• If only biopsy from metastasis can be obtained, the patient must have a previously resected or image proven tumor of the colon or rectum (scanning or endoscopy)
• Non-resectable metastatic spread
• Previously exposed to or intolerance or contraindications to standard systemic therapy, defined as

• oxaliplatin
• irinotecan
• 5-fluorouracil (or similar such as capecitabine, S1)
• VEGF inhibitor bevacizumab
• EGFR inhibitor panitumumab or cetuximab (if RAS/RAF wt)
• Progressive disease defined as progression according to RECIST 1.1
• ECOG performance status 0-2
• Age at least 18 years
• Adequate bone marrow, liver and renal function allowing systemic chemotherapy

• Absolute neutrophil count ≥1.5x10^9/l and thrombocytes ≥ 100x10^9/l.
• Bilirubin ≤ 1.5 x upper normal value and alanine aminotransferase ≤ 3 x upper normal value
• Calculated or measured renal glomerular filtration rate at least 30 mL/min
• Anticonception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject's male partner or hormonal contraceptive are acceptable
• Written and orally informed consent

Exclusion criteria

• Incapacity, frailty, disability, or comorbidity to a degree that according to the investigator is not compatible with participation in the protocol
• Other active malignant disease requiring therapy
• Other systemic anti-cancer therapy (palliative radiotherapy is allowed).
• Pregnant (positive pregnancy test) or breast feeding women