MedDRA version: 20.0 Level: LLT Classification code 10033605 Term: Pancreatic cancer metastatic System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10033606 Term: Pancreatic cancer non-resectable System Organ Class: 100000004864
Conditions
Interventions
Product Name: Oxaliplatin
Pharmaceutical Form: Solvent for solution for infusion
INN or Proposed INN: OXALIPLATIN
CAS Number: 61825-94-3
Sponsors
Vejle Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Non-resectable pancreatic cancer o Biopsy proven adenocarcinoma compatible with pancreatic origin (primary tumor or metastasis) o If only biopsy from metastasis can be obtained, the patient must have a previously resected or image proven tumor of the pancreas o Deemed non-resectable at a multidisciplinary conference • Candidate to standard systemic therapy, defined as one of o Gemcitabine monotherapy, o Gemcitabine and nab-paclitaxel combination, o Gemcitabine and capecitabine combination, o 5-fluorouracil, oxaliplatin and irinotecan combination (FOLFIRINOX), or o New standard treatments approved by the multidisciplinary cancer group ‘Dansk Pancreas Cancer Gruppe’ 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 o Absolute neutrophil count =1.5x10^9/l and thrombocytes = 100x10^9/l o Bilirubin = 3 x upper normal value and alanine aminotransferase = 5 x upper normal value o 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of the present study is to investigate the predictive value of pretreatment in-vitro testing of drug sensitivity to patient-derived tumoroids.;Secondary Objective: Not applicable;Primary end point(s): Predictive value of in-vitro testing defined as the ability to correctly predict response or resistance to first-line chemotherapy.;Timepoint(s) of evaluation of this end point: xxxxxxxxx | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Feasibility of selecting second-line therapy based on pre-treatment biopsies. 2. Time to failure of strategy (TFS) 3. Progression free survival (PFS) and overall survival (OS) 4. Response rate (RR) first- and second-line 5. Quality of life (QoL) 6. Dynamics of circulating tumor DNA during treatment ;Timepoint(s) of evaluation of this end point: xxxxxxxxxxxxxxxxxx | — |
Countries
Denmark
Contacts
Public ContactClinical Trial Unit, Oncology
Vejle Hospital
Outcome results
None listed