Clinical trial · Interventional
Predictive Value of Drug Sensitivity Testing Tumorspheres From Patients With Metastatic Colorectal Cancer
Predictive Value of In-vitro Testing Anti-cancer Therapy Sensitivity on Tumorspheres From Patients With Metastatic Colorectal Cancer
NCT03251612CI-TRIAL-00063290completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Based on sensitivity analysis | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Treatment
- description
- 1 drug or a combination of drugs considered standard anticancer treatment is given according to the result of the sensitivity analysis.
- interventionNames
- Drug: Based on sensitivity analysis
Primary outcomes (1)
- measure
- Progression free survival 8 weeks after start of treatment
- timeFrame
- 42-63 days after start of treatment
Secondary outcomes (4)
- measure
- Progression free survival
- timeFrame
- Every 8 weeks until progression or death up to 2.5 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDJensen 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. PMID 37143108