No small cell Lung cancer MedDRA version: 9.1 Level: LLT Classification code 10029519 Term: Non-small cell lung cancer stage III
Conditions
Interventions
Trade Name: Cisplatyl
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CISPLATIN
CAS Number: 15663271
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration numbe
Sponsors
CHU Limoges
Eligibility
Sex/Gender
All
Inclusion criteria
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) 1.5 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 = 40% theoretical, PaO2 >= 60 mm Hg, KCO >=60% theoretical - Weight loss =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Performans Status (ECOG)> 2 - Haematological function: neutrophils ULN, SGOT and / or SGPT> 2.5 x ULN - Respiratory Function: FEV 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of the Safety of a cisplatine/vinorelbine traitment;Secondary Objective: - 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 ;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. | — |
Countries
France
Outcome results
None listed