Neoadjuvant Electrochemotherapy for Colorectal Cancer - a Randomized Controlled Trial

NCT04816045 | Unknown Phase 1 DMC

• 1 other identifier: REG-032-2020
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Tumor stage

  Preoperative tumor stage will be compared with pathological assessment of the surgical specimen and comared between the two study arms using TNM stage

  6 months

Secondary Outcomes (7)

• Gene expressional changes in the tumor microenvironment

  6 months

• Composition of fusobacterium

  6 months

• PD-1/PD-L1

  6 months

• CD3

  6 months

• CD8

  6 months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Electrochemotherapy with bleomycin

Procedure: Electrochemotheraoy

Control

ACTIVE COMPARATOR

Electroporation with saline

Procedure: Electroporation with saline (placebo)

Interventions

Electrochemotheraoy PROCEDURE

Electrochemotherapy (ECT) is endoscopic electroporation in combination with bleomycin

Intervention

Electroporation with saline (placebo) PROCEDURE

Electroporation in the control group is performed endoscopically with saline

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Zealand University Hospital: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Electroporation; Sodium Chloride

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ismail Gögenur, DMSc

  Zealand University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Malene Broholm, MD

CONTACT

+45 56531500; malea@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients and investigators are blinded. The allocation list is located at the pharmacy.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 25, 2021
• Study Start: May 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 25, 2021

Record last verified: 2021-03