E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Malignant gastrointestinal bleeding |
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E.1.1.1 | Medical condition in easily understood language |
Bleeding due to a tumor in the gastrointestinal tract |
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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 | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10017936 |
E.1.2 | Term | Gastrointestinal bleeding |
E.1.2 | System Organ Class | 100000004856 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10007129 |
E.1.2 | Term | Cancer-related morbidities |
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 phase II, randomized controlled trial, is to evaluate the efficacy and long-term outcomes of calcium electroporation for clinically significant GI bleeding in non-curable cancer patients. Calcium electroporation will be compared with standard treatment options, including endoscopic interventions and radiotherapy. |
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E.2.2 | Secondary objectives of the trial |
To investigate recurrent bleeding and overall survival after calcium electroporation |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria • Patients must be mentally capable of understanding the information given. • Patients must give written informed consent. • Endoscopically assessable tumor for calcium electroporation. • Men or women aged at least 18 years. • Case reviewed by MDT (surgery, radiology, oncology). • ASA class I-III (Classification of the American Society of Anesthesiology) • Clinically significant GI bleeding, defined as one of the following: o Melena o Hematochezia o Hematamesis o Significant anemia
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E.4 | Principal exclusion criteria |
Exclusion criteria • Acute bleeding • Hemodynamic instability (Heart rate >100 beats per minute and systolic blood pressure <90 mmHg) • Bleeding from a non-malignant source • Uncorrectable coagulation disorder. • Patients with ICD or pacemaker units. • 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. • Pregnancy
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint • Recurrence of bleeding o Defined as clinically significant bleeding evaluated 4 weeks after study treatment
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Secondary endpoints • Elimination of the bleeding o Treatment success will be defined as no bleeding >3 days after the treatment • Recurrence of bleeding o Defined as clinically significant bleeding >7 after study treatment • Overall survival |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Evaluated at 1 week, 4 weeks and 3 months.
Patients are followed until death |
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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 | No |
E.6.4 | Safety | No |
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 | 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 | Yes |
E.8.2.3.1 | Comparator description |
Standard treatment, including endoscopic interventions and radiotherapy |
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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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | 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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |