E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The principal aim of this study is to compare the effectiveness of video-assisted thoracoscopic (VAT) cytoreductive pleurectomy against talc pleurodesis for patients with pleural effusion secondary to mesothelioma We have chosen pleurodesis with talc (either via an intercostal chest drain or during thoracoscopy) as the principal control group because these are widely available and commonly used treatments for management of malignant pleural effusion. The Primary objective is to compare the effectiveness of talc pleurodesis against video-assisted thoracoscopic cytoreductive surgery in terms of survival at one year. |
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E.2.2 | Secondary objectives of the trial |
Control of pleural effusion in each arm Assessment of procedure-related complications in each arm. Symptoms and quality of life at 3, 6 and 12 months from treatment date in each arm of the study. Length of hospital stay in each arm. Exercise tolerance at 3, 6 and 12 months from treatment date. Cost to the health service in terms of resources used for procedures, hospital bed usage and cost to primary and secondary care for 12 months from date of randomization. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Confirmed or suspected mesothelioma (any sub-type) 2. Associated pleural effusion present 3. Clinically fit and suitable for VAT cytoreductive pleurectomy 4. Able to give Informed consent |
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E.4 | Principal exclusion criteria |
1. Unfit for VAT pleurectomy 2. Absence of a pleural effusion 3. Previous attempted pleurodesis by any approach 4. Previous malignancy (Patients who have had a previous malignancy for which they are no longer receiving treatment are eligible to take part in the study provided that they have a confirmed diagnosis of mesothelioma. Those who have had a previous malignancy and do not have a confirmed diagnosis of mesothelioma will not be eligible to take part as we cannot be certain that the pleural disease/effusion is not related to the original cancer). 5. Age < 18 |
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E.5 End points |
E.5.1 | Primary end point(s) |
The final analysis will be on an intention to treat basis. The primary outcome, proportion surviving 12 months after treatment in the two groups, will be compared using Pearson's Chi-squared test. |
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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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 |
video-assisted thoracoscopic (VAT) cytoreductive pleurectomy |
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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 | 14 |
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 | Information not present in EudraCT |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 10 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 10 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |