Status:
UNKNOWN
Neoadjuvant Electrochemotherapy for Colorectal Cancer - a Randomized Controlled Trial
Lead Sponsor:
Zealand University Hospital
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 electrochemoth...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04816045
Start Date
May 1 2021
End Date
December 1 2023
Last Update
March 25 2021
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