Colorectal Cancer Metastatic
Conditions
Brief summary
The purpose of the present study is to investigate the benefit of anti-cancer therapy administered on the basis of drug sensitivity testing. This concerns colorectal cancer patients who have previously received standard treatment.
Interventions
DRUGBased on sensitivity analysis
* 5FU, infusional * Capecitabine * Oxaliplatin (FOLFOX) * Irinotecan (FOLFIRI) * FOLFOXIRI (triplet) * Bevacizumab * Panitumumab * Cetuximab * Regorafenib * Tas-102 * Ramucirumab * Aflibercept * Pembrolizumab * Nivolumab * Vinorelbine and capecitabine * Sorafenib * Gemcitabine and capecitabine * Olaparib * Epirubicin
Sponsors
Vejle Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival 8 weeks after start of treatment | 42-63 days after start of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival | Every 8 weeks until progression or death up to 2.5 years |
| Overall survival | Every 3 months up to 2.5 years |
| Response rate | Every 8 weeks until progression up to 2.5 years |
| Quality of life as measured by questionnaire EQ-5D-5L | Every 8 weeks up to 2.5 years |
Countries
Denmark, Germany
Outcome results
None listed