Neoadjuvant electrochemotherapy for colorectal cancer - a phase 2 trial
Key facts
- Where
- Koege, DániaSee the site
- Phase
- 2. fázis
Where in Dánia
- Region SjaellandKoege, DániaNo longer taking part
Trial details
- Who runs it
- Region Sjaelland
- Trial code
- NCT04816045EU 2025-520755-91-00
- Record updated
- 2025. július 8.
- Original description
To investigate if electrochemotherapy is an efficient treatment modality for tumor down staging compared with electroporation alone prior to intended curative surgery in patients undergoing treatment for colorectal cancer.Read full original descriptionShow less
Neoadjuvant electrochemotherapy for colorectal cancer - a randomized controlled trial
To investigate if electrochemotherapy is an efficient treatment modality for tumor down staging compared with electroporation alone prior to intended curative surgery in patients undergoing treatment for colorectal cancer.
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; Acute surgical resection; Previous cumulative dose of bleomycin exceeding 250mg/m2; 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; Medical history of severe pulmonary disease; Uncorrectable coagulation disorder; Myocardial insufficiency, defined as NYHA class >2; Renal impairment, defined as eGFR <40 ml/min; Pregnancy; BMI > 35; Patients with ICD or pacemaker units; Ongoing immunosuppressive treatment; Advanced tumor stages, clinical UICC stage IV.