E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The anti-tumoral effect of cannabis oil will be investigated in patients with untreatable HCC |
Het anti-tumorigene effect van cannabisolie zal onderzocht worden in patiënten met uitbehandeld HCC |
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E.1.1.1 | Medical condition in easily understood language |
The anti-tumoral effect of cannabis oil will be investigated in patients with untreatable HCC |
Het anti-tumoreffect van cannabisolie zal onderzocht worden in patiënten met uitbehandeld HCC |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
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 |
to study the anti-tumor effect of cannabis oil (THC10% / CBD5%) in untreatable HCC patients based on mRECIST and RECIST criteria |
het bestuderen van het antitumor effect van cannabis olie (THC10% / CBD5%) in uitbehandelde gevorderd HCC patiënten gebaseerd op mRECIST and RECIST criteria |
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E.2.2 | Secondary objectives of the trial |
to study quality of life using questionnaire EORTC-QLQ C30 en -HCC18 |
het bestuderen van kwaliteit van leven gebruik makend van vragenlijst EORTC-QLQ-C30 en -HCC18 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age =>18 yrs
- Histologically proven hepatocellular carcinoma
- MDT-advised best supportive care for untreatable advanced HCC or patients unable to undergo or denying treatment for advanced HCC.
- Minimal life expectancy of 3 months
- Willing and able to attend follow-up examinations
- Willing to stop driving, if applicable
- Signed informed consent
- Language: Dutch or English
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- Leeftijd =>18 yrs
- Histologisch bewezen hepatocellulair carcinoom
- MDO-advies 'best supportive care' of patienten die sorafenib behandeling weigeren of niet kunnen ondergaan
- minimale levensverwachting van 3 maanden
- Bereid en in staat zijn vervolgafspraken na te komen
- getekend informed consent
- Taal: Nederlands of Engels
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E.4 | Principal exclusion criteria |
- Mental conditions rendering the subject incapable to understand the nature, scope and consequences of the trial
- Contra-indications for medicinal cannabis oil:
o Psychotic disorders
o Cardiac arrhythmias
o Angina pectoris
o Pregnancy or lactation
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- Mentale conditie die ervoor zorgen dat de onderzoekspatients het idee, doel en consequenties van de studie niet begrijpen
- Contra-indicaties voor medicinale cannabis olie:
o Psychotische aandoeningen
o Hartritmestoornissen
o Angina pectoris
o Zwangerschap of borstvoeding gevend
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E.5 End points |
E.5.1 | Primary end point(s) |
to study the anti-tumor effect of cannabis oil (THC10% / CBD5%) in untreatable HCC patients by assessing tumor size at 6 months after starting treatment based on RECIST and mRECIST criteria |
het bestuderen van het antitumor effect van cannabis olie (THC10% / CBD5%) in uitbehandelde HCC patiënten door tumorgrootte te bepalen 6 maanden na het starten van de therapie gebaseerd op RECIST en mRECIST criteria |
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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) |
a. to study the anti-tumor effect of cannabis oil in untreatable HCC patients by assessing
- tumor size at 3 and 9 months after starting treatment based on RECIST en mRECIST criteria
- Tumor markers Alfa-foetoprotein (AFP) and des-gamma-carboxy-protrombine (DGCPT) at 3, 6 and 9 months
b. to study quality of life at 3, 6 and 9 months using questionnaire EORTC-QLQ C30 |
a. het bestuderen van antitumor effect van cannabis olie (THC10% / CBD5%) in uitbehandelde HCC patiënten door
- tumorgrootte te bepalen 3 en 9 maanden na het starten van de therapie gebaseerd op RECIST criteria
- bepalen van tumormarkers Alfa-foetoprotein (AFP) en des-gamma-carboxy-protrombine (DGCPT) 3, 6 en 9 maanden na het starten van de therapie
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
3 ,(6) and 9 months |
3, (6) en 9 maanden |
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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 | No |
E.6.5 | Efficacy | No |
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.8.3 |
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 | 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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LVLS |
Laatste bezoek van laatste onderzoekspatiënt |
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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 |