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

Study Overview
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Brief Summary
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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.

Official Title
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Predictive Value of In-vitro Testing Anti-cancer Therapy Sensitivity on Tumorspheres From Patients With Metastatic Colorectal Cancer

Conditions
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Colorectal Cancer Metastatic

Intervention / Treatment
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* Drug: Based on sensitivity analysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment<br>1 drug or a combination of drugs considered standard anticancer treatment is given according to the result of the sensitivity analysis. | Drug: Based on sensitivity analysis<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival 8 weeks after start of treatment |  | 42-63 days after start of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |