Colorectal CancerPhase 1/2NCT04816045
Neoadjuvant Electrochemotherapy for Colorectal Cancer - a Randomized Controlled Trial
A Phase 1/2 study testing Electrochemotheraoy in people with Colorectal Cancer, run by Zealand University Hospital.
Trial summary
This is a randomized controlled trial investigating efficacy of electrochemotherapy for early colorectal cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Electrochemotheraoy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 1 Dec 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
This is a randomized controlled trial investigating efficacy of electrochemotherapy for early colorectal cancer
Read the 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 electrochemotherapy, compared with electroporation alone, as a down staging and immune-response enhancing treatment prior to intended curative surgery. The study involves recruitment of patients with histologically verified rectal and sigmoid colon cancer with no indication for neoadjuvant chemoradiotherapy (experimental or standard care based) prior to intended curative surgery. In total the study will involve 24 patients, of these, 12 patients are treated with electrochemotherapy (bleomycin) and 12 patients with electroporation alone (placebo)
In relation to the intervention, clinical examination, blood samples, biopsies and questionnaires will be collected to evaluate safety, tumor respons and immunologic response to the treatment.
Patients will be followed for one month after the elective surgery.
- Conditions
- Colorectal Cancer
- Being tested
- Electrochemotheraoy, Electroporation with saline (placebo)
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrochemotheraoyProcedure or surgery
Electrochemotherapy (ECT) is endoscopic electroporation in combination with bleomycin
Electroporation with saline (placebo)Procedure or surgery
Electroporation in the control group is performed endoscopically with saline
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Electrochemotherapy with bleomycin Receives: Procedure: Electrochemotheraoy |
| Control | Active comparator | Electroporation with saline Receives: Procedure: Electroporation with saline (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor stage
Preoperative tumor stage will be compared with pathological assessment of the surgical specimen and comared between the two study arms using TNM stage
Measured: 6 months
Secondary outcomes (7)
Gene expressional changes in the tumor microenvironment
Biopises are collected before the intervention and compared with the surgical specimen using NanoString technology. The PanCancer IO 360 gene panel will be used, a predefined panel of 770 genes.
Measured: 6 months
Composition of fusobacterium
To characterize the spatial distribution and organization of bacteria in situ, some of the samples will be assessed microscopically. Confocal laser scanning microscopy will be performed on formalin-fixed, paraffin-embedded tissue of both diseased and normal tissue. This will allow us to investigate treatment affects the bacterial composition of fusobacterium.
Measured: 6 months
PD-1/PD-L1
Immunohistochemical staining for PD-1/PD-L1
Measured: 6 months
CD3
Immunohistochemical staining for CD3
Measured: 6 months
CD8
Immunohistochemical staining for CD8
Measured: 6 months
CD28
Immunohistochemical staining for CD28
Measured: 6 months
VAR2
Immunohistochemical staining for VAR2
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start1 May 2021 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ismail Gögenur, DMSc, Principal investigator, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816045
- Sponsor's protocol ID
- REG-032-2020
- Status last verified
- Mar 2021
- First submitted
- 24 Feb 2021
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Electrochemotherapy for Colorectal Cancer - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04816045
- Acronym / sponsor ID
- REG-032-2020
- Conditions
- Colorectal Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 electrochemotherapy, compared with electroporation alone, as a down staging and immune-response enhancing treatment prior to intended curative surgery. The study involves recruitment of patients with histologically verified rectal and sigmoid colon cancer with no indication for neoadjuvant chemoradiotherapy (experimental or standard care based) prior to intended curative surgery. In total the study will involve 24 patients, of these, 12 patients are treated with electrochemotherapy (bleomycin) and 12 patients with electroporation alone (placebo)
In relation to the intervention, clinical examination, blood samples, biopsies and questionnaires will be collected to evaluate safety, tumor respons and immunologic response to the treatment.
Patients will be followed for one month after the elective surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Procedure: ElectrochemotheraoyElectrochemotherapy with bleomycin |
| Control | Active comparator | Procedure: Electroporation with saline (placebo)Electroporation with saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectrochemotheraoyElectrochemotherapy (ECT) is endoscopic electroporation in combination with bleomycin | Procedure or surgery | Intervention |
| Electroporation with saline (placebo)Electroporation in the control group is performed endoscopically with saline | Procedure or surgery | Control |
Primary outcome
Tumor stage
Time frame: 6 months
Preoperative tumor stage will be compared with pathological assessment of the surgical specimen and comared between the two study arms using TNM stage
7 secondary outcomes
Gene expressional changes in the tumor microenvironment
Time frame: 6 months
Composition of fusobacterium
Time frame: 6 months
PD-1/PD-L1
Time frame: 6 months
CD3
Time frame: 6 months
CD8
Time frame: 6 months
CD28
Time frame: 6 months
VAR2
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ismail Gögenur, DMSc principal investigator
Zealand University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Electrochemotheraoy in people with Colorectal Cancer, run by Zealand University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Malene Broholm, MD (+45 56531500, malea@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor stage (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2021.