Electrochemotherapy - a novel treatment in oesophageal cancer

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Cancer [C04]; Esophageal cancer; MedDRA version: 21.0Level: LLTClassification code 10015362Term: Esophageal cancerSystem Organ Class: 100000004864

• Registration Number: EUCTR2020-002878-27-DK
• Lead Sponsor: Michael Patrick

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-13
• Last Update Posted: 17 May 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1.Male or female =18 years old.
2.Histological verified malignant tumor in the esophagus, including the GEJ.
3.Subjects must have been evaluated by an MDT and been considered unsuitable for potential curative treatment.
4.Subjects must not have received any previous oncological treatment due to this current cancer.
5.Performance status ECOG/WHO < 2.
6.Expected survival > 3 months.
7.Platelets = 50 billion/l, International Normalized Ratio (INR) < 1,5 (medical correction is allowed, e.g. correction of a high INR using vitamin K).
8.Se-creatinine < 150 ?mole/l, (Cr-51-EDTA-clearance > 40 mL/min) are excluded. (Se-creatinine > 150 ?mole/l triggers a Cr-51-EDTA-clearence test).
9.Subjects must be willing and able to comply with the procedure such as agreed follow-up visits.
10.Sexually active women who can become pregnant should use adequate contraception during the trial (pill, spiral, injection of prolonged progestin, sub dermal implantation, hormone-containing vaginal devices, transdermal patches).
11.Subjects must give written informed consent.

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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

1.Coagulation disorder that cannot be corrected.
2.Subjects with renal dysfunction (Cr-51-EDTA-clearance < 40 mL/min are excluded).
3.Subjects with a clinically significant cardiac arrhythmia.
4.Pregnancy or lactation/breastfeeding.
5.Concurrent treatment with another investigational medicinal product.
6.Contraindications for use of bleomycin, including; acute pulmonary infection, severe pulmonary disease and allergic reactions to bleomycin observed in previous treatment.
7.Subjects who have previously undergone a regime of bleomycin with a cumulative dose of > 240.000 UI/m2.
8.Stenosis that prevents passage of the endoscope with the device attached.
9.Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified