E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Malignant pleural effusions |
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E.1.1.1 | Medical condition in easily understood language |
Fluid which builds up in the lining around the lungs due to cancer |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10035605 |
E.1.2 | Term | Pleural mesothelioma malignant advanced |
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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066721 |
E.1.2 | Term | Pleural effusion recurrent |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10035606 |
E.1.2 | Term | Pleural mesothelioma malignant localised |
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 | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10035607 |
E.1.2 | Term | Pleural mesothelioma malignant recurrent |
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 | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10035598 |
E.1.2 | Term | Pleural effusion |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10035608 |
E.1.2 | Term | Pleural metastases |
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 | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061352 |
E.1.2 | Term | Pleural neoplasm |
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 | 14.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10035612 |
E.1.2 | Term | Pleural therapeutic procedures |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10035603 |
E.1.2 | Term | Pleural mesothelioma |
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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10046099 |
E.1.2 | Term | Unspecified pleural effusion |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10026673 |
E.1.2 | Term | Malignant pleural effusion |
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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10062754 |
E.1.2 | Term | Pleural cavity drainage |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10014313 |
E.1.2 | Term | Effusion pleural |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10068942 |
E.1.2 | Term | Implantable pleural catheter insertion |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10059518 |
E.1.2 | Term | Pleural mesothelioma malignant |
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 IPC-PLUS trial is a study to help determine the best way to manage patients who develop fluid around the lung as a result of cancer (malignant pleural effusion). The aim is to compare outcomes in two groups of patients. The first group will be treated with an indwelling pleural catheter (IPC, or tunnelled chest tube) to help drain away the fluid, and will then be given an inert placebo substance (saline) into the drain before being followed up. The second group will receive the same type of IPC to drain away the fluid, but will then be given an injection of sterile talc powder into the drain instead of placebo. Our primary objective is to determine whether introducing talc through the IPC leads to an improved rate of successful pleurodesis, whereby the two linings of the lung are stuck together to prevent further fluid build-up. This is a randomised controlled trial, which means patients will be randomly allocated to receive either the placebo injection or the talc injection |
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E.2.2 | Secondary objectives of the trial |
We shall be evaluating the impact of combining an IPC and talc on patients' symptoms, specifically local pain and breathlessness. This will be done using validated visual-analogue assessments, which involves simply putting a mark on a line. We are also monitoring patients' subjective quality of life scores using serial questionnaires. Patients will undergo regular follow-up in order to determine if there are any significant medical complications to combining these two treatments. At these visits, patients will also have a thoracic ultrasound scan to determine whether the fluid is becoming contained in separate pockets, or 'loculated,' as this can affect the ease with which drainage occurs. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Symptomatic malignant pleural effusion, agreed at appropriate local / regional MDT to require IPC, defined as pleural fluid in the context of: a.Histocytologically proven pleural malignancy, OR b.Otherwise unexplained pleural effusion in the context of clinically proven cancer elsewhere, OR c.Radiologically proven pleural malignancy as diagnosed in normal clinical practice on thoracic CT in the absence of histocytological proof 2.Expected survival greater than 2 months 3.Written informed consent to trial participation. |
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E.4 | Principal exclusion criteria |
1. Age < 18 years. 2. Females who are pregnant or lactating. 3. Patient unable to provide informed consent. 4. Previous attempts at pleurodesis on same side as effusion requiring management. 5. Previously documented adverse reaction to talc or lidocaine. 6. Community services unable to drain indwelling pleural catheter at least twice per week. 7. Evidence of extensive lung entrapment on CXR or CT, or significant fluid loculation on ultrasound scan, to a level which would normally be a contraindication to attempted talc pleurodesis or IPC insertion. 8. Other contraindication to indwelling pleural catheter insertion 9. Patient has no access to a telephone |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measure is the proportion of patients who achieve successful pleurodesis within 5 weeks of randomisation Pleurodesis is defined as the collection of less than or equal to 20mls of fluid on three consectutive occasions from the IPC, with chest opacification on the side of the effusion at less than 25%, as judged by two independent clinicians. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Evaluation of pleurodesis success will occur at 5 weeks post IPC placement. |
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E.5.2 | Secondary end point(s) |
1. Self-reported quality of life status, measured at 14, 28, 42, 56, and 70 days, using the EQ-5D health questionnaire 2. Self-reported VAS scores, measured daily from randomisation to 10 weeks post-randomisation, for a. Thoracic pain b. Breathlessness 3. Total volume of pleural fluid drained from randomisation to 10 weeks post-randomisation 4. All-cause mortality up to 10 weeks post randomisation. 5. Number of hospital inpatient bed-days required from randomisation to 10 weeks post-randomisation 6. Degree of loculation of pleural fluid following talc instillation as judged by thoracic ultrasound and septation score at two-weekly intervals for 10 follow-up period 7. Pleurodesis success at 10 weeks post randomisation 8. Time from randomisation to successful pleurodesis, up to 10 weeks |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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) | 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 | No |
E.8.1.3 | Single blind | Yes |
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 | Yes |
E.8.2.3 | Other | No |
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
| 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 | 4 |
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 | 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
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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 | 2 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
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 | 2 |