Electric pulse treatment in esophageal cancer

Phase 1

• Conditions: Esophageal cancer; MedDRA version: 19.0Level: LLTClassification code 10056267Term: Gastroesophageal cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-005246-59-DK
• Lead Sponsor: Michael Patrick Achiam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-08
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Male or female =18 years old.
2.Histological verified adenocarcinoma in the gastro-oesophageal junction.
3.Expected survival > 3 months.
4.Performance status ECOG/WHO < 2.
5.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).
6.Platelets = 50 billion/L, International Normalized Ratio (INR) < 1.5. Medical correction is allowed, e.g. correction of a high INR using vitamin K.
7.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).
8.Subjects must be willing and able to comply with the procedure such as agreed follow-up visits.
9.Subjects must give written informed consent.
10.The patient has a progressing disease, despite previously treatment with palliative chemo/radio therapy
OR
11.The patient has a progressing disease, despite previously treatment with palliative radio therapy and he/she can not tolerate palliative systemic chemotherapy treatment.

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 4
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

1.Coagulation disorder that cannot be corrected.
2.Subjects with renal dysfunction (Cr-51-EDTA-clearance < 40 ml/min are excluded. If p-creatinine > 150 micromole/L triggers a Cr-51-EDTA-clearence test).
3.Subjects with a clinically significant cardiac arrhythmia.
4.Diabetes.
5.Pregnancy or lactation/breastfeeding.
6.Concurrent treatment with an investigational medicinal product.
7.Contraindications for use of bleomycin, including acute pulmonary infection, severe pulmonary disease and allergic reactions to bleomycin observed in previous treatment.
8.Subjects who have previously undergone a regime of bleomycin with a cumulative dose of > 240.000 units/m2.
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. This includes stenosis that prevents passage of the endoscope.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: All participants will have 3 schedualed follow up appointments. <br>7 days: Life of quality questionaries and dysphagia score. <br>1 months: Life of quality questionaries and dysphagia score + PET-MRI<br>2 months: Life of quality questionaries and dysphagia score + PET-MRI<br><br>All participants will be followed for at least 2 months. ;Main Objective: The primary objectives of this phase I trial are to investigate the safety and side effects of treating patients with inoperable GEJ cancer with electroporation delivered through an endoscopic system. ;Secondary Objective: The secondary outcome is an evaluation of the response measured by:<br>•Positron emission tomography–magnetic resonance imaging (PET-MRI)<br>•Dysphagia by Mellow and Pinka’s dysphagia score <br>•Patient experience of treatment by Quality of life questionnaires, EORTC QLQ-C30.<br>;Primary end point(s): Evaluation of safety and feasibility of this new method. <br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Evaluation of tumour regression/reduction in volume measured via PET-MRI.<br>Evaluation of the participants subject experience via life of quality questionaries and dysphagia score. ;Timepoint(s) of evaluation of this end point: PET-MRI at 4 and 8 weeks after initial treatment. <br>Evaluation of the participants subject experience via life of quality questionaries and dysphagia score, day 7, week 4, week 8.