E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Cancer in the colon and rectum |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061451 |
E.1.2 | Term | Colorectal cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The aim of this randomized trial, is to establish the safety and efficacy of electrochemotherapy in patients with colorectal cancer, as an additive treatment prior to intended curative surgery. The electroporation regime in this trial will be delivered through and endoscopic device, EndoVE®. The CliniporatorTM will be used for pulse generation |
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E.2.2 | Secondary objectives of the trial |
Secondary objective is to evaluate tumor response of the treatment. Furthermore, we plan to investigate local and systemic immunologic response |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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)
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Patients will be evaluated 5 times during a 30 day periode |
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E.5.2 | Secondary end point(s) |
To investigate if electrochemotherapy will induce immunologic invasion of the primary tumor To investigate if the treatment will induce a systemic immunologic response.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Patients will be evaluated 5 times during a 30 day periode |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |