E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Colorectal cancer |
Kolorektal cancer |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10052358 |
E.1.2 | Term | Colorectal cancer metastatic |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10010039 |
E.1.2 | Term | Colorectal and anal neoplasms malignancy unspecified |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10010023 |
E.1.2 | Term | Colorectal neoplasms malignant |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10010040 |
E.1.2 | Term | Anal and colorectal neoplasms NEC |
E.1.2 | System Organ Class | 100000004856 |
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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 primary objectives of this study are to investigate tumour regression / reduction in volume in patients with inoperable colorectal cancer treated with Electroporation delivered through an Endoscopic System, and to assess the safety of this treatment. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective of this study is to investigate change to the tumour shape and structure in patients with inoperable colorectal cancer treated with Electroporation delivered through an endoscopic system. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Histologically verified colorectal tumour.
2. Case reviewed by a multidisciplinary team (MDT) (surgery, radiology, oncology, gastroenterology) and there are no curable options with the standard of care. The MDT considers all available treatment options and enrolment to this study is agreed as being appropriate;
Or the case is curable but patient refuses to undergo the standard of care. The MDT considers all possible alternatives, which are also discussed with the patient, and the MDT considers enrolment to this study as being the most appropriate option;
Or patients with advanced local disease with impending obstruction on endoscopic evaluation who are otherwise not suitable for surgical intervention or stenting, the MDT would also consider these patients for enrolment into this study.
3. Men or women aged at least 18 years.
4. Performance status (Karnofsky > 60% or ECOG/WHO < 2).
5. Treatment free interval of at least 2 weeks after previously applied therapy.
6. Patients must be mentally capable of understanding the information given.
7. Patients must give written informed consent.
8. a) A female of Non-Childbearing potential (i.e. physiologically incapable of becoming pregnant) is eligible to participate in the study if she:
- has had a hysterectomy
- has had a bilateral oophorectomy (ovariectomy) - has had a bilateral tubal ligation
- Is post-menopausal:
• Performance status (Karnofsky >60 OR WHO < 2).
• Treatment free interval of at least 2 weeks after previously applied therapy.
• Patients must be mentally capable of understanding the information given.
• Patients must give written informed consent. |
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E.4 | Principal exclusion criteria |
1. Coagulation disorder
2. Patients with pre-existing renal dysfunction are excluded.
[Note: Creatinine clearance will be measured for all patients. For Bleomycin treatment: creatinine clearance must be greater than 40ml/min.]
3. Patients with a clinically manifested arrhythmia or with a pacemaker
4. Patients with epilepsy.
5. Pregnancy or lactation/breastfeeding.
6. Patient known to be Hepatitis B/C or HIV positive.
7. Concurrent treatment with an investigational medicinal product or participation in another clinical study.
8. Patients who have undergone a regime of Bevacizumab in the previous 4 weeks.
9. 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 requirements.
10. Highly inflamed colon tissue which is ulcerated and bleeding.
11. patients with colorectal stent |
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E.5 End points |
E.5.1 | Primary end point(s) |
Evaluation of tumour regression / reduction in volume as measured via CT or MRI scan at 3, & 6 months (24 weeks) post the initial procedure.
Continuous assessment of safety by reviewing adverse events as they arise. The investigation will be put on hold if unacceptable safety issues are outstanding. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
• Tumor nodule observation (measurement) 6, 12 and 18 and 24 weeks after treatment • Clinical evaluation of the patient • Measurement of the tumour mass • Photodocumentation
• six weeks will be used as the minimum duration of the reported response. |
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E.5.2 | Secondary end point(s) |
Evaluation of change to the tumour shape and structure as measured by colonoscopy: 3, and 6 months (24 weeks) post the initial procedure. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
10 patient accrual and treatments complete without report of adverse event |
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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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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 | No |
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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Final follow up on last patient (10) six months after first treatment. |
Afsluttende opfølgning på sidste patient (10) seks måneder efter første behandling. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |