Electrochemotherapy of Posterior Resection Surface for Lowering Disease Recurrence Rate in Pancre… (NCT04281290) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Electrochemotherapy of Posterior Resection Surface for Lowering Disease Recurrence Rate in Pancreatic Cancer (PanECT Study)
Slovenia10 participantsStarted 2020-07-13
Plain-language 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 10patients in phase I clinical study and additional 10patients 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.
Who can participate
Age range18 Years
SexALL
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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.
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.
What they're measuring
1
Incidence of Postprocedural Complications for Evaluation of Feasibility and Safety