Clinical trial NCT04281290: Electrochemotherapy of Posterior Resection Surface for Lowering Disease Recurrence Rate in Pancreatic Cancer (PanECT Study)
Official title: Electrochemotherapy of Posterior Resection Surface for Lowering Disease Recurrence Rate in Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Pancreas Cancer
Keywords: Pancreatic cancer
Electrochemotherapy
Bleomycin
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: Institute of Oncology Ljubljana
First posted: 2020-02-24
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 cancer, the posterior resection surface will be treated with ECT with the intention to lower disease recurrence rate.

The study will include 20 patients in phase I clinical study and additional 20 patients in phase II clinical study (or in the extension of the clinical study), which will fulfill inclusion criteria.

Treatment effectiveness will be evaluated by US or CT imaging, to detect early local recurrence of the disease. Long term effectiveness of the treatment will be evaluated by frequent and precise patient follow-up. During follow-up clinical examination, laboratory tests, tumor markers (Ca 19-9 and CEA) and US/CT imaging will be performed.

The secondary objectives of the trial are to quantify the impact of the treatment on the patient's quality of life, tolerance to the therapy and suitability for larger study to be conducted.

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 extension of the clinical study).

After surgical resection of pancreatic cancer, the posterior resection surface will be treated with purpose to lower disease recurrence rate. Plate electrodes will be used for ECT treatment, the electrodes will be placed between choledochal cut-end, truncus celiacus, remaining of the pancreas and aortal lymph nodes.

ECT will be performed within 8-28 min after intravenous in bolus administration of bleomycin (15 mg/m2). Triggering of electric pulses will be synchronized with ECG signals, through the ECG triggering device AccuSync to avoid delivery of pulses in vulnerable period of the heart.

All patients will be treated after the procedure has been thoroughly described to them and have signed informed consent.

Eligibility criteria: Inclusion Criteria:

1. Patients with resectable pancreatic cancer.
2. Histologically confirmed and/or based on radiological imaging and laboratory tests confirmed pancreatic cancer by multidisciplinary team for pancreatic tumors.
3. Age more than 18.
4. Life expectancy more than 3 months.
5. Performance status - Karnofsky ≥ 70 or WHO \< or 2.
6. Treatment free interval 2-5 weeks, depending on the drugs used.
7. Patient must be mentally capable of understanding the information given.
8. Patient must give informed consent.
9. Patient must be discussed at the multidisciplinary team for pancreatic tumors before entering the trial.

Exclusion Criteria:

1. Secondary primary tumor, except surgically treated noninvasive cancer of cervix, or surgically or irradiated basal cell carcinoma.
2. Proven visceral, bone or diffuse metastases.
3. 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.
4. Significant reduction in respiratory function.
5. Age less than 18 years.
6. Cumulative dose of 250 mg/m2 bleomycin received.
7. Allergic reaction to bleomycin.
8. Patients with epilepsy.
9. Patients with arrhythmias.
10. Patients with heart failure or pacemaker.
11. Pregnancy.
12. Patient incapable of understanding the aim of the study or disagree with the entering into the clinical study.

Primary outcomes:
measure: Evaluation of feasibility and safety
timeFrame: 7 days after operation
Secondary outcomes:
measure: Disease-free Survival
timeFrame: 1, 3, 6, 12, 18 and 24 months after operation
measure: Overall Survival
timeFrame: From the time of surgical treatment until 5 years after surgery
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana, Ljubljana, Slovenia
Study officials:
affiliation: University Medical Centre Ljubljana, Ljubljana, Slovenia
name: Mihajlo Djokic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Centre Ljubljana, Ljubljana, Slovenia
name: Blaz Trotovsek, MD, PhD
role: STUDY_DIRECTOR
affiliation: Institute of Oncology, Ljubljana, Slovenia
name: Gregor Sersa, PhD
role: STUDY_DIRECTOR
affiliation: University Medical Centre Ljubljana, Ljubljana, Slovenia
name: Zan Cebron, MD
role: STUDY_CHAIR
affiliation: University Medical Centre Ljubljana, Ljubljana, Slovenia
name: Miha Petric, MD
role: STUDY_CHAIR
affiliation: University Medical Centre Ljubljana, Ljubljana, Slovenia
name: David Badovinac, MD
role: STUDY_CHAIR
affiliation: Institute of Oncology, Ljubljana, Slovenia
name: Masa Bosnjak, PhD
role: STUDY_CHAIR
affiliation: Institute of Oncology, Ljubljana, Slovenia
name: Bostjan Markelc, PhD
role: STUDY_CHAIR
affiliation: Institute of Oncology, Ljubljana, Slovenia
name: Maja Cemazar, PhD
role: STUDY_CHAIR
References:
citation: Djokic M, Cemazar M, Popovic P, Kos B, Dezman R, Bosnjak M, Zakelj MN, Miklavcic D, Potrc S, Stabuc B, Tomazic A, Sersa G, Trotovsek B. Electrochemotherapy as treatment option for hepatocellular carcinoma, a prospective pilot study. Eur J Surg Oncol. 2018 May;44(5):651-657. doi: 10.1016/j.ejso.2018.01.090. Epub 2018 Feb 2.
citation: Bimonte S, Leongito M, Granata V, Barbieri A, Del Vecchio V, Falco M, Nasto A, Albino V, Piccirillo M, Palaia R, Amore A, Giacomo Rd, Lastoria S, Setola SV, Fusco R, Petrillo A, Izzo F. Electrochemotherapy in pancreatic adenocarcinoma treatment: pre-clinical and clinical studies. Radiol Oncol. 2016 Feb 16;50(1):14-20. doi: 10.1515/raon-2016-0003. eCollection 2016 Mar 1.
citation: Tafuto S, von Arx C, De Divitiis C, Maura CT, Palaia R, Albino V, Fusco R, Membrini M, Petrillo A, Granata V, Izzo F; ENETS Center of Excellence Multidisciplinary Group for Neuroendocrine Tumors in Naples (Italy). Electrochemotherapy as a new approach on pancreatic cancer and on liver metastases. Int J Surg. 2015 Sep;21 Suppl 1:S78-82. doi: 10.1016/j.ijsu.2015.04.095. Epub 2015 Jun 27.