Concomitant Radio-chemotherapy in the Elderly

Study Overview
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Brief Summary
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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.

Official Title
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Phase II Study Evaluating Treatment With Oral Navelbine and Cisplatin Administered Weekly and Concomitant Radiotherapy in Elderly Patients With no Operable NSCLC

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Cisplatin IV
* Drug: Vinorelbine
* Radiation: Radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental<br> | Drug: Cisplatin IV<br>* Cisplatin IV 30 mg/m2/ (Day 1, Day 8, Day 15, Day 22, Day 29, Day 36)<br>Drug: Vinorelbine<br>* Vinorelbine per os 30 mg/m2/(day1, day8, day15, day22, day29, day36<br>Radiation: Radiotherapy<br>* 66Gy, 33 fractions, 6 week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute toxicity |  | during treatment and during the 4 weeks following the end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late toxicity |  | 6 months after the end of the treatment | 
| Overall response rate |  | 4 weeks after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Locally advanced lung cancer, Elderly patients, NSCLC