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Electrochemotherapy of Posterior Resection Surface for Lowering Disease Recurrence Rate in Pancreatic Cancer (PanECT Study) (PanECT)

Primary Purpose

Pancreas Cancer

Status

Terminated

Phase

Phase 1

Locations

Slovenia

Study Type

Interventional

Intervention

Electrochemotherapy - electroporation with Cliniporator Vitae® and chemotherapy drug Bleomycin PHC 15 e. (United States Pharmacopeia - USP)

About this trial

This is an interventional treatment trial for Pancreas Cancer focused on measuring Pancreatic cancer, Electrochemotherapy, Bleomycin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

University Medical Centre Ljubljana, Ljubljana, Slovenia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental group

Arm Description

Cliniporator Vitae® and chemotherapy drug Bleomycin PHC 15 e. (United States Pharmacopeia - USP)

Outcomes

Primary Outcome Measures

Evaluation of feasibility and safety

Every patient will be closely followed-up after operation with clinical examination and blood tests (hemogram, comprehensive metabolic panel, liver panel) according to the study protocol (day 1, 3, 7 after operation). In case of detected abnormalities additional imaging (US and/or CT) will take place. Findings will be noted and reported in line with Clavien-Dindo classification of surgical complications. The primary measure is to detect complications after surgery and to determine whether the complication is related to electrochemotherapy treatment or not.

Secondary Outcome Measures

Disease-free Survival

Disease-free survival is defined as the amount of time a subject survives without disease recurrence after treatment. Recurrence is defined as significant elevation of tumor markers Ca19-9 and CEA after operation (normal value of Ca19-9 is under 37.0 kU/L, normal value of CEA is under 4.2 µg/L). The appearance of one or more lesions on imaging investigation (US and/or CT) is also considered a recurrence. The tumor markers and imaging investigations will be performed according to study protocol (tumor markers 1, 3, 6, 12 and 24 months after operation; imaging 1, 3, 6, 12, 18 and 24 months after operation - the imaging method will be CT or MR with or without contrast, with the exception of 1 and 18 months after the operation when an US will be performed).

Overall Survival

Overall survival is defined as the amount of time a subject survives after therapy. Patient enrolled in the study will be followed up for at least five years. During first two years after surgery follow-up will be as written above, after that period patient will be followed-up according every 6 months.

Full Information

NCT ID

NCT04281290

First Posted

January 14, 2020

Last Updated

March 9, 2021

Sponsor

University Medical Centre Ljubljana

Collaborators

Institute of Oncology Ljubljana

1. Study Identification

Unique Protocol Identification Number

NCT04281290

Brief Title

Electrochemotherapy of Posterior Resection Surface for Lowering Disease Recurrence Rate in Pancreatic Cancer (PanECT Study)

Acronym

PanECT

Official Title

Electrochemotherapy of Posterior Resection Surface for Lowering Disease Recurrence Rate in Pancreatic Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Terminated

Why Stopped

After enrolling 3 participants the safety and efficacy of the planned treatment is questionable, thus we decided to terminate the study.

Study Start Date

July 13, 2020 (Actual)

Primary Completion Date

March 9, 2021 (Actual)

Study Completion Date

March 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Medical Centre Ljubljana

Collaborators

Institute of Oncology Ljubljana

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreas Cancer

Keywords

Pancreatic cancer, Electrochemotherapy, Bleomycin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

Cliniporator Vitae® and chemotherapy drug Bleomycin PHC 15 e. (United States Pharmacopeia - USP)

Intervention Type

Procedure

Intervention Name(s)

Electrochemotherapy - electroporation with Cliniporator Vitae® and chemotherapy drug Bleomycin PHC 15 e. (United States Pharmacopeia - USP)

Intervention Description

Procedure: Electrochemotherapy Exploration, anesthesia, pancreatic cancer resection, bleomycin administration, electroporation, formation of all anastomoses. Device: Cliniporator Vitae® Positioning of plate electrodes according to landmarks, 8-28 min after administration of bleomycin application of electric pulses (8 pulses, duration 100 microseconds, frequency 8 Hz with amplitude adequate to cover the whole treated lesion with electric field necessary for reversible plasma membrane permeabilization, approximately 1000V/cm), removal of electrodes. The maximum duration of procedure is 90 minutes, after liver mobilization. Drug: Bleomycin PHC 15 e. (United States Pharmacopeia - USP) Intravenous bolus administration of bleomycin (15 mg/m2)

Primary Outcome Measure Information:

Title

Evaluation of feasibility and safety

Description

Time Frame

7 days after operation

Secondary Outcome Measure Information:

Title

Disease-free Survival

Description

Time Frame

1, 3, 6, 12, 18 and 24 months after operation

Title

Overall Survival

Description

Time Frame

From the time of surgical treatment until 5 years after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Overall Study Officials: