Unresectable pancreatic cancer MedDRA version: 21.0 Level: LLT Classification code 10033606 Term: Pancreatic cancer non-resectable System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Bleomycyni sulfas
CAS Number: 9041-93-4
Concentration unit: IU international unit(s)
Concentration type: up to
Concentration
Sponsors
Uniwersytet Medyczny im. Piastów Slaskich we Wroclawiu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age over 18 years (male and female) 2. Written informed consent 3. Histopathological confirmed adenocarcinoma of the pancreas (intraoperative examination possible) 4. Lesion defined as unresectable (infiltration of mesenteric or portal vein exceeding 180 degrees or its thrombosis, infiltration of the hepatic artery, celiac artery or superior mesenteric artery) on abdominal CT/MRI not older than 60 days (stage III), or patients after resection with local recurrence of the neoplastic process 5. Tumor size not larger than 6 cm on a CT/MRI scan not older than 60 days 6. Patients undergoing chemotherapy or patients with a “de novo” diagnosis of pancreatic cancer 7. ECOG performance status: 0,1 or 2 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 34 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 39
Exclusion criteria
Exclusion criteria: 1. Age under 18 years. 2. Inability to give consent in writing. 3. Pregnant or lactating women 4. Significant cardiac abnormality (rhythm other than sinus rhythm). 5. Patients with pacemakers or any implanted stimulation device. 6. Allergy to contrast media that would compromise the ability to perform imaging after surgery. 7. Documented history of allergy to bleomycin. 8. Documented history of pulmonary fibrosis. 9. Patient with metastatic stage IV disease. 10. INR > 1,5 without use of anticoagulants. 11. Body temperature >38°C or any infection requiring antibiotic therapy within 24 hours prior to study treatment. 12. Overuse or addiction to alcohol, drugs or any other substances (caffeine and nicotine excluded). 13. Any circumstances, that in the Investigator’s judgement may prevent the patient from participating in the study, undergoing the study assessments in accordance with the protocol or bear unjustified risk to the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate efficacy and safety of irreversible electroporation (IRE), calcium (CaCl2) electroporation and electrochemotherapy (ECT) in patients with pancreatic cancer;Secondary Objective: To evaluate overall survival, decrease of body weight loss and decrease of pain level, as well as quality of life improvement Exploratory objectives: - Biomarkers analysis (Ca 19-9). - Morphology and biochemistry analysis (including but not limited to, albumin, protein, lipase, amylase levels, CRP, procalcitonin). - The inflammatory response in IRE (irreversible electroporation), ECT (electrochemotherapy) and CaEP (calcium electroporation). ;Primary end point(s): Progression-free survival (PFS) defined as the time from initiation of study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first.;Timepoint(s) of evaluation of this end point: 1 month, 3 month and 6 month, and 12 months after treatment. Thereafter, by telephone, every 6 months until the Sponsor announces the end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Patient overall survival (OS) defined as the proportion of patients remaining alive from the initiation of study treatment until the last follow-up visit. 2. Body weight change in predefined timepoints 3. Pain level (VAS scale) 4. Quality of life EORTC QLQ-PAN26 and WHOQOL-BREF Exploratory endpoints: 1. Levels of biomarkers (Ca 19-9 in 1,4, 6 days after surgery [+/- 1 day] and during standard follow-up visits) 2. Changes in morphology and biochemistry panel (including but not limited to, albumin, protein, lipase, amylase levels, CRP, procalcitonin) at the timepoints described by schedule of assessments. 3. Progression-free survival (PFS) defined as the time from the diagnosis to the first occurrence of disease progression or death from any cause, whichever occurs first. 4. Patient overall survival (OS) defined as the proportion of patients remaining alive from the diagnosis until the last follow-up visit. ;Timepoint(s) of evaluation of this end point: 1 month, 3 month and 6 month, and 12 months after treatment. Thereafter, by telephone, every 6 months until the Sponsor announces the end of the study. | — |
Countries
Poland
Contacts
Public ContactClinical Trials Information
Maria Wolkowinska/Uniwersytet Medyczny im. Piastów Slaskich we Wroclawiu
Outcome results
None listed