Endoscopic Assisted Electrochemotherapy in Addition to Neoadjuvant Treatment of Locally Advanced Rectal Cancer

NCT03040180 | Unknown Phase 2 DMC

• 1 other identifier: REG-32-2016
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of neoadjuvant electrochemotherapy on locally advanced rectal cancer (UICC II-III) in an intended curative clinical setting, using an endoscopic electroporation device (EndoVE).

Conditions

Locally Advanced Rectal Cancer; Electrochemotherapy; Neoadjuvant Therapy; Down Staging

Keywords

Neoplasms; Neoplasms, primary; Cancer; Colorectal cancer; rectal cancer; rectal cancer, locally advanced; Electrochemotherapy; Electroporation; Neoadjuvant therapy; Antineoplastic, antibodies; Bleomycin; Pathologic processes; Neoplastic processes

Outcome Measures

Primary Outcomes (1)

• Histopathologic tumor regression following electrochemotherapy

  Number of participants with histopathologic tumor regression following elctrochemotherapy as assesed by histopathological evaluation of Tumor Regression Grade (Mandard Classification, TRG 1-5)

  4 weeks

Secondary Outcomes (4)

• Treatment safety of electrochemotherapy

  4 months

• Treatment safety of surgery following electrochemotherapy

  4 weeks

• Tumor regression according to Hybrid PET/MRI following electrochemotherapy

  4 weeks

• Tumor Immunologic response following electrochemotherapy

  4 weeks

Study Arms (2)

Electrochemotherapy with bleomycin

EXPERIMENTAL

Systemic injection of bleomycin followed by electroporation of the primary tumor. Bleomycin administration: 15.000 IU/m2 BSA. BSA by Du Bois formula.

Drug: Electrochemotherapy with bleomycin; Device: EndoVE

Standard care

NO INTERVENTION

Standard care

Interventions

Electrochemotherapy with bleomycin DRUG

Systemic injection, once only treatment

Also known as: ATC code L01DC01, EV substance code SUB00844MIG

Electrochemotherapy with bleomycin

EndoVE DEVICE

Electroporation using an endoscopic electroporation device

Also known as: Endoscopic electroporation

Electrochemotherapy with bleomycin

Eligibility Criteria

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

You may qualify if:

• Patient must be mentally capable of understanding the information given.
• Patients must give written informed consent.
• Men or women aged at least 18 years.
• Histologically verified rectal tumor (adenocarcinoma)
• Case reviewed by MDT (surgery, radiology, oncology). Case considered curable with neoadjuvant therapy followed by surgical excision (UICC stadium II-III).
• ASA class I-III (Classification of the American Society of Anesthesiology)

You may not qualify if:

• Coagulation disorders
• Highly inflamed gastrointestinal tissue which is ulcerated and bleeding
• Patients with ICD or pacemaker units.
• Patients with epilepsy.
• Pregnancy or lactation/breastfeeding.
• Patients with known Hepatitis B/C or HIV infection.
• Patients who have undergone treatment with bevacizumab within 4 weeks prior to enrolment in this trial.
• Patients with concomitant use of phenytoin.
• Patients with concomitant use of clozapine.
• 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.
• Patients with contraindications for PET/MRI scan:
• Advanced tumor stage, UICC stage IV.
• Acute pulmonary infection.
• Medical history of severe pulmonary disease.

Sponsors & Collaborators

• Zealand University Hospital: lead
• Herlev Hospital: collaborator
• Rigshospitalet, Denmark: collaborator

Study Sites (2)

Department of Oncology

Herlev, Capitol Region, 2730, Denmark

RECRUITING

Department of Surgery

Roskilde, 4000, Denmark

RECRUITING

MeSH Terms

Conditions

Neoplasms; Colorectal Neoplasms; Rectal Neoplasms; Pathologic Processes; Neoplastic Processes

Interventions

Electrochemotherapy; Bleomycin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Electroporation Therapies; Electroporation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Ismail Gögenur, Professor

  Department of Surgery, Zealand University Hospital

  PRINCIPAL INVESTIGATOR

• Julie Gehl, MD, DMSc

  Department of oncology, herlev Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ismail Gögenur, MD, DMSc

CONTACT

+45 26336426; igo@regionsjaelland.dk

Rasmus P Vogelsang, MD

CONTACT

+45 27351103; rvo@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: February 2, 2017
• Study Start: January 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: September 1, 2019
• Last Updated: January 25, 2019

Record last verified: 2019-01

Locations

DK (2)