E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
No small cell Lung cancer |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029519 |
E.1.2 | Term | Non-small cell lung cancer stage III |
|
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 |
Assessment of the Safety of a cisplatine/vinorelbine traitment |
|
E.2.2 | Secondary objectives of the trial |
- Assessment of the efficacy of a cisplatine/vinorelbine traitment - Assessment of the free survival after at 1, 2 and 3 years - Assessment of the survivalat 1, 2 and 3 years
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patient older than 70 years
- Independent Patient (IADL= 0, ADL = 0, no geriatric syndrome, low comorbidity (Charlson comorbidity index of 3 or 4), depression score of 0-1 )
- Performans Status (ECOG) < 1
- Life expectancy greater than 12 weeks
- Haematological function: neutrophils> 1.5 x 109 / l, hemoglobin> 9.5 g / dl, platelets> 100 x 109 / l
- Renal function: creatinine clearance >= 50 ml / min calculated by the formula of Levey-abbreviated MDRD
- Normal liver function: bilirubin <ULN, SGOT and / or SGPT <2.5 x ULN
- Respiratory function: VEMS >= 40% theoretical, PaO2 >= 60 mm Hg, KCO >=60% theoretical
- Weight loss <10% of usual weight in the last 3 months
- Informed Consent given
- Non-small cell lung cancer proven cytological or histologically , inoperable stage - IIIAN2 or stage IIIB
- Presence of at least one measurable lesion
- At least three weeks between surgery and initiation of treatment
- No previous treatment with chemotherapy or radiotherapy for lung cancer |
|
E.4 | Principal exclusion criteria |
- Performans Status (ECOG)> 2
- Haematological function: neutrophils <1.5 x 109 / l, hemoglobin <9.5 g / dl, platelets <100 x 109 / l
- Renal function: creatinine clearance <50 ml / min calculated by the formula of Levey-abbreviated MDRD
- Hepatic bilirubin> ULN, SGOT and / or SGPT> 2.5 x ULN
- Respiratory Function: FEV <40% theoretical KCO <60% theoretical, PaO2 <60 mmHg
- Peripheral neuropathy grade> 1
- Unstable cardiac pathology requiring treatment
- Deafness
- Neurological or psychiatric disorders
- Uncontrolled infection
- All other organic diseases that may prevent the inclusion in the trial
- Suscebibility to steroids
- Suscebibility to cisplatin and vinoreblbine
- Previous history of cancer except basal cell cancer, carcinoma in situ of the cervix treaty or any other cancer treated by surgery alone or radiotherapy alone without extra-thoracic recurrence for 5 years
- Significant disease affecting the functioning of the gastrointestinal
- Patient enrolled into a clinical trial in last month
- Metastatic disease with bone marrow infiltration
- Superior vena cava syndrome
- Drain pleural effusion
- Lymphangitis carcinomatous
- Operable Lung Cancer
- Previous treatment for lung cancer: radiotherapy, chemotherapy, hormonal treatment, endobronchial desobstruction within the last week |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The number of patients with at least one toxicity of grade 3 or 4 (excluding nausea and vomiting) or grade 4 hematologic toxicity and asthenia during treatment and during the next 4 weeks after end of treatment. |
|
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 | 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) | 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 | No |
E.8.1.2 | Open | No |
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) | 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 | 34 |
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 | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |