Non Small Cell Lung Cancer
Conditions
Keywords
Locally advanced lung cancer, Elderly patients, NSCLC
Brief summary
The purpose of this study is to evaluate the safety of non small cell lung cancer (NSCLC) treatment with cisplatin and oral vinorelbine administered weekly associated with concomitant radiotherapy in elderly patients.
Interventions
DRUGCisplatin IV
Cisplatin IV 30 mg/m2/ (Day 1, Day 8, Day 15, Day 22, Day 29, Day 36)
DRUGVinorelbine
Vinorelbine per os 30 mg/m2/(day1, day8, day15, day22, day29, day36
RADIATIONRadiotherapy
66Gy, 33 fractions, 6 week
Sponsors
Pierre Fabre Laboratories
University Hospital, Limoges
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute toxicity | during treatment and during the 4 weeks following the end of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Late toxicity | 6 months after the end of the treatment |
| Overall response rate | 4 weeks after treatment |
Countries
France
Outcome results
None listed