Colorectal Cancer Metastatic Clinical Trial
Official title:
Predictive Value of In-vitro Testing Anti-cancer Therapy Sensitivity on Tumorspheres From Patients With Metastatic Colorectal Cancer
Verified date | January 2023 |
Source | Vejle Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | March 21, 2022 |
Est. primary completion date | August 23, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Oncology, Aalborg University Hospital | Aalborg | |
Denmark | Department of Oncology, Rigshospitalet | Copenhagen | |
Denmark | Departmen of Oncology, Vejle Hospital | Vejle | |
Germany | Universitätsklinikum Hamburg - Eppendorf, Universitäres Cancer Center Hamburg (UCCH) | Hamburg |
Lead Sponsor | Collaborator |
---|---|
Vejle Hospital |
Denmark, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression free survival 8 weeks after start of treatment | 42-63 days after start of treatment | ||
Secondary | Progression free survival | Every 8 weeks until progression or death up to 2.5 years | ||
Secondary | Overall survival | Every 3 months up to 2.5 years | ||
Secondary | Response rate | Every 8 weeks until progression up to 2.5 years | ||
Secondary | Quality of life as measured by questionnaire EQ-5D-5L | Every 8 weeks up to 2.5 years |
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