Status:
TERMINATED
Electrochemotherapy of Posterior Resection Surface for Lowering Disease Recurrence Rate in Pancreatic Cancer (PanECT Study)
Lead Sponsor:
University Medical Centre Ljubljana
Collaborating Sponsors:
Institute of Oncology Ljubljana
Conditions:
Pancreas Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The aim of the study is to evaluate toxicity and effectiveness of electrochemotherapy (ECT) with bleomycin in pancreatic cancer in clinical study phase I and II. After surgical resection of pancreatic...
Detailed Description
The study will be conducted on patients with resectable pancreatic cancer. 20 patients will be included in phase I clinical study and additional 20 patients in phase II clinical study (or in the exten...
Eligibility Criteria
Inclusion
- Patients with resectable pancreatic cancer.
- Histologically confirmed and/or based on radiological imaging and laboratory tests confirmed pancreatic cancer by multidisciplinary team for pancreatic tumors.
- Age more than 18.
- Life expectancy more than 3 months.
- Performance status - Karnofsky ≥ 70 or WHO \< or 2.
- Treatment free interval 2-5 weeks, depending on the drugs used.
- Patient must be mentally capable of understanding the information given.
- Patient must give informed consent.
- Patient must be discussed at the multidisciplinary team for pancreatic tumors before entering the trial.
Exclusion
- Secondary primary tumor, except surgically treated noninvasive cancer of cervix, or surgically or irradiated basal cell carcinoma.
- Proven visceral, bone or diffuse metastases.
- Life-threatening infection and/or heart failure and/or liver failure and/or renal failure (creatinine more than 150 µmol/L) other severe systemic pathologies.
- Significant reduction in respiratory function.
- Age less than 18 years.
- Cumulative dose of 250 mg/m2 bleomycin received.
- Allergic reaction to bleomycin.
- Patients with epilepsy.
- Patients with arrhythmias.
- Patients with heart failure or pacemaker.
- Pregnancy.
- Patient incapable of understanding the aim of the study or disagree with the entering into the clinical study.
Key Trial Info
Start Date :
July 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2021
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04281290
Start Date
July 13 2020
End Date
March 9 2021
Last Update
March 12 2021
Active Locations (1)
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1
University Medical Centre Ljubljana, Ljubljana, Slovenia
Ljubljana, Slovenia, 1000