Clinical trial · Interventional
Neoadjuvant Electrochemotherapy for Colorectal Cancer - a Randomized Controlled Trial
NCT04816045CI-TRIAL-00050889unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a randomized controlled trial investigating efficacy of electrochemotherapy for early colorectal cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electrochemotheraoy | Procedure | — | UNRESOLVED |
| Electroporation with saline (placebo) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intervention
- description
- Electrochemotherapy with bleomycin
- interventionNames
- Procedure: Electrochemotheraoy
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- Electroporation with saline
- interventionNames
- Procedure: Electroporation with saline (placebo)
Primary outcomes (1)
- measure
- Tumor stage
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.