E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
malignant pleural mesothelioma |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10029104 |
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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 |
To study the feasibility of 3 courses of induction chemotherapy, followed by extrapleural pneumonectomy and postoperative radiotherapy in patients with malignant pleural mesothelioma. |
|
E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
♦ Age < 70 years ♦ WHO performance status 0-1 (see Appendix B) ♦ Patient should be considered fit enough to receive chemotherapy, to undergo a pneumonectomy and receive postoperative radiotherapy. The responsible physician, surgeon and radiation therapist should judge the required fitness prior to registration, taking into account the results of all the relevant (i.e. pulmonary, cardiac) examinations. ♦ Pathologically proven malignant pleural mesothelioma (all subtypes accepted) ♦ cT3N1M0 or less according to UICC TNM classification (see Appendix F, Ref. 6) ♦ No N2 or N3 lymph nodes involvement (pathologically confirmed), cervical mediastinoscopy required ♦ No clinical invasion of mediastinal structures (heart, aorta, spine, esophagus, etc.) ♦ No widespread chest wall invasion, only focal chest wall lesions are acceptable ♦ No clinical or radiological evidence of ‘shrinking hemithorax’ ♦ No prior chemotherapy for mesothelioma ♦ No prior radiotherapy of the lower neck, thorax, and upper abdomen ♦ No secondary primary malignancy except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years before without recurrence (excluding melanoma, breast cancer and hypernephroma). ♦ Adequate hematological, hepatic and renal function ♦ White Blood Cell Count > 3,5 x 109/l ♦ Absolute Neutrophil Count (ANC) > 1,5 x 109/l ♦ Platelet count > 100 x 109/l ♦ Hemoglobin > 11 g/dl ♦ Bilirubin < 1.5 x upper normal limit ♦ ASAT/ALAT < 1.5 x upper normal limit ♦ Alkaline phosphatase < 1.5 x upper normal limit ♦ Creatinine clearance > 60 ml/min ♦ Acceptable (predicted) post-radiotherapy renal function, as indicated by semiquantitative isotope renography, with a relative contribution of the contralateral kidney of at least 40% ♦ No pre-existing sensory neurotoxicity > grade 1 according Common Terminology Criteria for Adverse Events (CTCAE) v3.0 ( http://ctep.cancer.gov/reporting/ctc.html). ♦ No clinically significant third-space fluid (for example pleural effusions or ascites) that cannot be managed with thoracentesis or pleurodesis (according to institutional practice) ♦ No uncontrolled infection ♦ Patients of reproductive potential must agree to use a reliable method of birth control during protocol treatment and for 3 months following the end of protocol treatment. Women of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test. ♦ Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial ♦ Before patient registration in the trial, written informed consent must be obtained and documented according to national and local regulatory requirements and the local rules followed in the institution. |
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E.4 | Principal exclusion criteria | |
E.5 End points |
E.5.1 | Primary end point(s) |
Success of treatment which is defined as a patient who received the full protocol treatment (with allowance for some dose adjustments detailed in the protocol), is still alive 90 days after end of the protocol treatment without progression nor G3-G4 toxicity. |
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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 | Yes |
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 | Information not present in EudraCT |
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 | 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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |