Randomized experimental treatment for colorectal cancer using an endoscopic device in combination with bleomycin or saline.

Phase 1

• Conditions: Colorectal cancer; MedDRA version: 21.0Level: PTClassification code 10061451Term: Colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-000835-33-DK
• Lead Sponsor: Zealand University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-26
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

•Patients must be mentally capable of understanding the information given.
•Patients must give written informed consent.
•Endoscopically suspected or histologically verified malignant tumor of the rectum or sigmoid colon.
•Tumor described as passable at index endoscopy.
•Men or women aged at least 18 years.
•Case reviewed by MDT (surgery, radiology, oncology). Case considered curable with standard surgical resection.
•ASA class I-II (Classification of the American Society of Anesthesiology)

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 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

•Indication for neoadjuvant chemoradiation or chemotherapy prior to surgery
•Uncorrectable coagulation disorder.
•Patients with ICD or pacemaker units.
•Ongoing immunosuppressive treatment.
•Patients with concomitant use of phenytoin.
•Myocardial insufficiency, defined as NYHA class >2
•Concurrent treatment with an investigational medicinal product.
•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 recruitments.
•Advanced tumor stages, clinical UICC stage IV.
•Acute surgical resection.
•Pregnancy
•Medical history of severe pulmonary disease.
•Previous cumulative dose of bleomycin exceeding 250mg/m2.
•BMI > 35

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this randomized trial, is to establish the<br>safety and efficacy of electrochemotherapy in patients with colorectal<br>cancer, as an additive treatment prior to intended curative surgery. The<br>electroporation regime in this trial will be delivered through and<br>endoscopic device, EndoVE®. The CliniporatorTM will be used for pulse<br>generation;Secondary Objective: Secondary objective is to evaluate tumor response of the treatment.<br>Furthermore, we plan to investigate local and systemic immunologic<br>response;Primary end point(s): To investigate if electrochemotherapy is an efficient treatment modality for tumor down staging compared with electroporation alone prior to intended curative surgery in patients undergoing treatment for colorectal cancer.;Timepoint(s) of evaluation of this end point: Patients will be evaluated 5 times during a 30 day periode

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To investigate if electrochemotherapy will induce immunologic invasion of the primary tumor<br>To investigate if the treatment will induce a systemic immunologic response. <br>;Timepoint(s) of evaluation of this end point: Patients will be evaluated 5 times during a 30 day periode