E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Unresectable non metastatic stage III non small cell lung carcinoma eligible for concomitant radiochemotherapy |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10038666 |
E.1.2 | Term | Respiratory and mediastinal neoplasms malignant and unspecified |
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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 induction concurrent chemoradiotherapy followed by consolidation chemotherapy will improve survival in comparison to induction chemotherapy followed by consolidation concurrent chemoradiotherapy in patients with unresectable locally advanced non-small cell lung cancer |
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E.2.2 | Secondary objectives of the trial |
- to determine the objective response rate between the two therapeutic approaches - to determine the toxicity between the two therapeutic approaches - to determine the local control rate obtained in each arm
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Men or women aged ≥ 18 years old - Histological or cytological diagnosis of non-small cell carcinoma of the lung - Initially unresectable non-metastatic stage III disease - Availability for participating in the detailed follow-up of the protocol - Presence of an evaluable or measurable lesion - Written informed consent - No functional or anatomical contraindication to chest irradiation - Irradiation technically possible
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E.4 | Principal exclusion criteria |
- Prior treatment with chemotherapy, radiotherapy or surgery - Performance status < 60 on the Karnofsky scale - 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) - Neutrophils < 2,000/mm³ - Platelet cells < 100,000/mm3 - Serum bilirubin > 1.5 mg/100 ml - Hepatic disease contra-indicating the administration of docetaxel and/or GOT or GPT ≥ 2.5x the normal value and/or alkaline phosphatase ≥ 5x the normal value - 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) or uncontrolled angina pectoris - Congestive cardiac failure or cardiac arrhythmia requiring medical treatment - Uncontrolled infectious disease - Symptomatic polyneuropathy - Auditive impairment contra-indicating cisplatin administration - Serious medical or psychological factors which may prevent adherence to the treatment schedule - Malignant pleural or pericardial effusion - Homolateral supraclavicular lymph node excepting upper lobe lesion - Heterolateral supraclavicular lymph node - Allergy or known hypersensitivity to docetaxel or cisplatin - Women of child bearing potential not consenting to use adequate contraceptive precautions - Female subject who is pregnant or breastfeeding - Aberrations from the radiotherapy guidelines
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of the study will be to compare the distributions of the survival duration between the two arms. |
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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 | 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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 17 |
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 total number of events to be observed is 178 and should be achieved with randomisation of 123 patients in each arm of the study. |
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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 |