Phase II Study Evaluating Treatment With Oral Navelbine and Cisplatin Administered Weekly and Concomitant Radiotherapy in Elderly Patients With no Operable NSCLC
Inclusion Criteria:
- Age ≥ 70 years
- Independent patients (based on the score of geriatric frailty: IADL = 0, ADL = 0, no
geriatric syndrome, low comorbidity (comorbidity index of Charlson to 3 or 4),
depression score 0-1)
- Performance Status (ECOG) ≤ 1
- Weight loss <10% of usual weight in the last 3 months
- Life expectancy greater than 12 weeks
- Hematologic function: neutrophils> 1.5 x 10**9 / l, hemoglobin> 9.5 g / dl, platelets
> 100 x 10**9 / l)
- Renal function: creatinine clearance ≥ 50 ml / min calculated by the formula of MDRD
- Normal liver function: bilirubin < Limit of Normal (ULN), SGOT and / or SGPT <2.5 x
UNL
- Respiratory Function: FEV ≥ 40% predicted, PaO2 ≥ 60 mm Hg, KCO ≥ 60% predicted
- Patient affiliated to a social security regimen or beneficiary of such regimen
- Informed consent signed
The disease
- Pathological anatomy: CBP non-small cell (squamous cell carcinoma, adenocarcinoma,
large cell carcinoma, undifferentiated carcinoma) histologically or cytologically
proven
- Stage IIIAN2 considered inoperable stage IIIB
- Presence of at least one measurable target
- Delay at least three weeks between surgery and initiation of treatment
- No prior treatment with chemotherapy or radiotherapy for lung cancer
Exclusion Criteria:
- Age < 70 years
- Performance Status (ECOG) ≥ 2
- Hematologic function: neutrophils <1.5 x 10**9 / l, hemoglobin <9.5 g / dl, platelets
<100 x 10**9 / l)
- Renal function: creatinine clearance <50 ml / min calculated by the formula of MDRD
- Hepatic: bilirubin> Upper Limit of Normal (ULN), SGOT and / or SGPT> 2.5 x ULN
- Respiratory Function: FEV <40% predicted, KCO <60% predicted, PaO2 <60 mmHg
- Peripheral neuropathy grade> 1
- Unstable cardiac pathology requiring treatment (heart failure, angor of effort,
arrhythmia) or previous myocardial infarction older than 12 months
- Deafness not paired or deafness requiring major achievement of an audiogram-cons may
indicate taking cisplatin
- Neurological or psychiatric disorders prohibiting the understanding of the test
- Previous history of cancer except basal cell cancer, carcinoma in situ of the cervix
treated or any other cancer treated with surgery alone or radiotherapy alone
extra-thoracic recurrence-free 5 years
- Significant malabsorption syndrome or disease affecting the functioning of the
gastrointestinal tract
The disease
- Pathological anatomy: Bronchioloalveolar carcinoma, neuroendocrine carcinoma, small
cell carcinoma
- Metastatic disease
- Pleural drain
- Carcinomatous lymphangitis
- Operable Cancer
- Previously treated for lung cancer disease: radiotherapy, chemotherapy, hormonal
therapy, endobronchial suctioning older less than eight days