E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
This phase II study aim to determine if radical radiochemotherapy on the mediastinum after lobectomy can be associated with significant long term survival in patients with initially unresectable stage III non-small cell lung cancer responding to induction chemotherapy but in which the residual disease (lung plus mediastinal diseases) is too large to be treated by radiotherapy. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10029105 |
E.1.2 | Term | Neoplasms malignant site unspecified NEC |
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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 determine if radical radiochemotherapy on the mediastinum after lobectomy can be associated with significant long term survival in patients with initially unresectable stage III NSCLC responding to induction chemotherapy but in which the residual disease is too large to be treated by radiotherapy. |
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E.2.2 | Secondary objectives of the trial |
- to determine the operative mortality and morbidity - to determine the toxicity of radiochemotherapy - to determine the local control rate
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Histological or cytological diagnosis of non-small cell carcinoma of the lung - Initially stage III NSCLC - Pathologically proven N2 or N3 disease - Any response to induction chemotherapy (whatever the regimen administered) - Disease still not fully resectable (because of extensive mediastinal N disease) and not suitable for radical radiotherapy (single field) after induction chemotherapy - Lobectomy possible for the treatment of T disease - Availability for participating in the detailed follow-up of the protocol - Informed consent
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E.4 | Principal exclusion criteria |
- Prior treatment with radiotherapy or surgery - Karnofsky PS < 60 - Functional or anatomical contra-indication to mediastinal radiotherapy - Functional or anatomical contra-indication to surgical lobectomy - A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or cured malignant tumour (more than 5 year disease-free interval) - malignant pleural or pericardial effusion - Neutrophils < 2,000/mm³ - Platelet cells < 100,000/mm3 - Serum bilirubin > 1.5 mg/100 ml - Serum creatinine > 1.5 mg/100 ml and/or creatinine clearance < 60 ml/min - Recent myocardial infarction (less than 3 months prior to date of diagnosis) - Congestive cardiac failure or cardiac arrhythmia requiring medical treatment - Uncontrolled infectious disease - Hearing loss - Symptomatic polyneuropathy - Serious medical or psychological factors which may prevent adherence to the treatment schedule |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of the study is the rate of patients alive without progression at 5 years |
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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) | 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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 14 |
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 | 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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The standard therapy for this patients population leads to less than 1% of patients alive at 5 years. With this combined approach, it is considered that a rate less than 5% is unacceptable and should lead to the rejection of the treatment and that a rate of at least 15% should be detected by the study with a power of 90%. With these assumptions, it is required to recruit 75 patients. |
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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 | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |