Etude de phase II évaluant un traitement par cisplatine et vinorelbine orale administrés de façon hebdomadaire et radiothérapie concomitante chez le sujet âgé indépendant atteint de cancer broncho-pulmonaire non à petites cellules localisé non opérable. - RACCOSA
- Conditions
- o small cell Lung cancerMedDRA version: 9.1Level: LLTClassification code 10029519Term: Non-small cell lung cancer stage III
- Registration Number
- EUCTR2009-012413-21-FR
- Lead Sponsor
- CHU Limoges
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 49
- 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
- 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Assessment of the Safety of a cisplatine/vinorelbine traitment;Secondary Objective: - Assessment of the efficacy of a cisplatine/vinorelbine traitment<br>- Assessment of the free survival after at 1, 2 and 3 years<br>- Assessment of the survivalat 1, 2 and 3 years<br>;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.
- Secondary Outcome Measures
Name Time Method