E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with intermediate stage hepatocellualr carcinoma. |
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E.1.1.1 | Medical condition in easily understood language |
Patients with inoperable primary liver cancer. |
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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 |
Compare the efficacy of radioembolization (with the medical device TheraSphere) to chemoembolization (with the medical device DC Bead), for patients with intermediate stage hepatocellular carcinoma. Primary endpoint is time to progression. |
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E.2.2 | Secondary objectives of the trial |
Secondary endpoints: overall survival, tumor response, toxicities/adverse events, treatment related effect on total liver function, quality of life and treatment-related costs (cost-effectiveness). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Diagnosis HCC
- Intermediate stage HCC as defined by the BCLC criteria, i.e. >3 lesions >3cm in size, or 1 lesion >5cm in size (BCLC stage B )
- absence of extrahepatic disease
- Age > 18 years
- Child-Pugh A-B7
- ECOG performance status (PST) 0-1 |
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E.4 | Principal exclusion criteria |
- Inadequate bone marrow function (hemoglobulin <6.0 mmol/l, absolute neutrophil count < 1.5 x 109/l, platelet count <60 x 109/l)
- Inadequate liver function (bilirubin >45 μmol/l (or 2.6 mg/dl), albumin <28 g/l, AST/ALT >5x upper limit of normal (ULN))
- Inadequate renal function (creatinine >1.5x ULN)
- Compromised biliary system
- Hypersensivity to doxorubicin
- Pregnancy or breast feeding
- >50% of liver involvement
- main portal vein (right, left or common trunk) thrombosis
- Patients who are declared incompetent or suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis
- Previous local treatment of study target lesion(s)
- Allergy for i.v. contrast used (Visipaque®)
- Life expectancy <3 months or otherwise impossible follow-up
- Patients in whom hepatic artery catheterization is contraindicated; such as patients with vascular abnormalities or bleeding diathesis (indicated by a PT >6 seconds over control) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Time to Progression, defined as the time elapsed since the start of treatment until the determination of progressive disease (according to the modified RECIST criteria) on post treatment imaging (contrast enhanced MRI or CT)). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Post treatment imaging is performed at 1 month after baseline (the date of the first treatment), 3 months after baseline and at 3 monthly intervals thereafter for two years. |
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E.5.2 | Secondary end point(s) |
Overall survival, tumor response, toxicities/adverse events, treatment related effect on total liver function, quality of life and treatment-related costs (cost-effectiveness).
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
On regular intervals during the duration of the trial. |
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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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 |
the medical device TheraSphere (MDS Nordion) |
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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.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
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
|
Definition of the end of the trial is provided in the research protocol. The end of the trial is the last visit of the last subject participating in 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 | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |