Status:
COMPLETED
Predictive Value of Analysing Tissue From Patients With Metastatic Pancreatic Cancer for Drug Sensitivity
Lead Sponsor:
Vejle Hospital
Conditions:
Metastatic Pancreatic Cancer
Eligibility:
All Genders
18+ years
Brief Summary
It will be investigated whether it is possible to predict the effect or lack of effect of first-line treatment by analysing cancer cells from the individual patient receiving standard first line treat...
Eligibility Criteria
Inclusion
- Non-resectable pancreatic cancer
- Biopsy proven adenocarcinoma compatible with pancreatic 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 pancreas
- Deemed non-resectable at a multidisciplinary conference
- Candidate to standard systemic therapy, defined as one of
- Gemcitabine monotherapy,
- Gemcitabine and nab-paclitaxel combination,
- Gemcitabine and capecitabine combination,
- 5-fluorouracil, oxaliplatin and irinotecan combination (FOLFIRINOX), or
- New standard treatments approved by the multidisciplinary cancer group 'Danish Pancreatic Cancer Group' in the inclusion period.
- Measurable disease 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 ≤ 3 x upper normal value and alanine aminotransferase ≤ 5 x upper normal value
- Calculated or measured renal glomerular filtration rate at least 30 mL/min
- Contraception 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
- Potentially resectable disease
- 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 :
February 25 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 22 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03821870
Start Date
February 25 2019
End Date
February 22 2023
Last Update
May 1 2023
Active Locations (1)
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1
Departmen of Oncology, Vejle Hospital
Vejle, Denmark