Status:
COMPLETED
Predictive Value of Drug Sensitivity Testing Tumorspheres From Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Vejle Hospital
Conditions:
Colorectal Cancer Metastatic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 previousl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2022
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03251612
Start Date
September 22 2017
End Date
March 21 2022
Last Update
January 18 2023
Active Locations (4)
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1
Department of Oncology, Aalborg University Hospital
Aalborg, Denmark
2
Department of Oncology, Rigshospitalet
Copenhagen, Denmark
3
Departmen of Oncology, Vejle Hospital
Vejle, Denmark
4
Universitätsklinikum Hamburg - Eppendorf, Universitäres Cancer Center Hamburg (UCCH)
Hamburg, Germany