Neoadjuvant Electrochemotherapy for Colorectal Cancer - a Randomized Controlled Trial

NCT ID: NCT04816045

Last Updated: 2021-03-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2023-12-01

Brief Summary

This is a randomized controlled trial investigating efficacy of electrochemotherapy for early colorectal cancer

Detailed Description

This is a phase 2 randomized controlled trial. The study is blinded. The aim of this study is to establish the safety and efficacy of treating patients with early colorectal cancer with electrochemotherapy, compared with electroporation alone, as a down staging and immune-response enhancing treatment prior to intended curative surgery. The study involves recruitment of patients with histologically verified rectal and sigmoid colon cancer with no indication for neoadjuvant chemoradiotherapy (experimental or standard care based) prior to intended curative surgery. In total the study will involve 24 patients, of these, 12 patients are treated with electrochemotherapy (bleomycin) and 12 patients with electroporation alone (placebo)

In relation to the intervention, clinical examination, blood samples, biopsies and questionnaires will be collected to evaluate safety, tumor respons and immunologic response to the treatment.

Patients will be followed for one month after the elective surgery.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention

Electrochemotherapy with bleomycin

Group Type: ACTIVE_COMPARATOR

Electrochemotheraoy

Intervention Type: PROCEDURE

Electrochemotherapy (ECT) is endoscopic electroporation in combination with bleomycin

Control

Electroporation with saline

Group Type: ACTIVE_COMPARATOR

Electroporation with saline (placebo)

Intervention Type: PROCEDURE

Electroporation in the control group is performed endoscopically with saline

Interventions

Electrochemotheraoy

Electrochemotherapy (ECT) is endoscopic electroporation in combination with bleomycin

Intervention Type: PROCEDURE

Electroporation with saline (placebo)

Electroporation in the control group is performed endoscopically with saline

Intervention Type: PROCEDURE

Eligibility Criteria

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)

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
• Renal impairment, defined as eGFR <40 ml/min

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zealand University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ismail Gögenur, DMSc

Role: PRINCIPAL_INVESTIGATOR

Zealand University Hospital

Central Contacts

Malene Broholm, MD

Role: CONTACT

malea@regionsjaelland.dk

+45 56531500

Other Identifiers

REG-032-2020

Identifier Type: -

Identifier Source: org_study_id