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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Other | 1 drug or a combination of drugs considered standard anticancer treatment is given according to the result of the sensitivity analysis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Based on sensitivity analysis | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival 8 weeks after start of treatment | 42-63 days after start of treatment |
| 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 |
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Inclusion Criteria:
Metastatic colorectal cancer
Previously exposed to or intolerance or contraindications to standard systemic therapy, defined as
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
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:
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| Name | Affiliation | Role |
|---|---|---|
| Lars H Jensen, MD | Vejle Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, Aalborg University Hospital | Aalborg | Denmark | ||||
| Department of Oncology, Rigshospitalet |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37143108 | Derived | Jensen LH, Rogatto SR, Lindebjerg J, Havelund B, Abildgaard C, do Canto LM, Vagn-Hansen C, Dam C, Rafaelsen S, Hansen TF. Precision medicine applied to metastatic colorectal cancer using tumor-derived organoids and in-vitro sensitivity testing: a phase 2, single-center, open-label, and non-comparative study. J Exp Clin Cancer Res. 2023 May 5;42(1):115. doi: 10.1186/s13046-023-02683-4. |
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|
| 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 |
| Copenhagen |
| Denmark |
| Departmen of Oncology, Vejle Hospital | Vejle | Denmark |
| Universitätsklinikum Hamburg - Eppendorf, Universitäres Cancer Center Hamburg (UCCH) | Hamburg | Germany |