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

NCT03040180 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-01-25

No results posted yet for this study

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

Interventions

DRUG

Electrochemotherapy with bleomycin

Systemic injection, once only treatment

DEVICE

EndoVE

Electroporation using an endoscopic electroporation device

Sponsors & Collaborators

  • Herlev Hospital

    collaborator OTHER

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Zealand University Hospital

    lead OTHER

Principal Investigators

  • Ismail Gögenur, Professor · Department of Surgery, Zealand University Hospital

  • Julie Gehl, MD, DMSc · Department of oncology, herlev Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2019-06-30
Completion
2019-09-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03040180 on ClinicalTrials.gov