Calcium Electroporation for Early Colorectal Cancer

NCT03694080 | Unknown Phase 1 DMC

• 1 other identifier: REG-188-2017
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is an explorative, phase I clinical trial. The aim of this study is to establish the safety and efficacy of treating patients with early colorectal cancer with calcium electroporation prior to intended curative surgery.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

  Safety will be evaluated through registration of adverse events related to the treatment. CTCAE will be used

  42 days

Secondary Outcomes (7)

• Histopathological characterization of the tumor

  14 days

• Immunologic infiltration of the tumor tissue after calcium electroporation

  14 days

• Immunoscore classification

  14 days

• Systemic immune response according to cytokine analysis

  42 days

• Systemic immune response according to flow cytometri

  42 days

Study Arms (1)

Calcium Electroporation treatment

EXPERIMENTAL

Calcium electroporation for colorectal cancer as a preoperative treatment before elective surgery.

Combination Product: Calcium electroporation

Interventions

Calcium electroporation COMBINATION_PRODUCT

Patients with potentially curable colorectal rectal cancer will be treated preoperatively

Calcium Electroporation treatment

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.
• Histologically verified adenocarcinoma 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:

• Uncorrectable coagulation disorder.
• Highly inflamed gastrointestinal tissue which is ulcerated and bleeding
• Patients with ICD or pacemaker units.
• Ongoing immunosuppressive treatment.
• Patients with concomitant use of phenytoin.
• 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.
• Indication for neoadjuvant chemoradiation or chemotherapy prior to surgery
• Acute surgical resection.
• Pregnancy

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Department of Surgery, Zealand University Hospital

Køge, 4600, Denmark

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

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

Study Officials

• Ismail Gögenur, DMSc

  Zealand University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Malene Broholm Andersen, MD

CONTACT

+45 41272742; malea@regionsjaelland.dk

Ismail Gögenur, DMSc

CONTACT

igo@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: October 3, 2018
• Study Start: November 1, 2018
• Primary Completion: May 1, 2020
• Study Completion: September 1, 2020
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

DK (1)