Concomitant Radio-chemotherapy in the Elderly

Phase 2

Completed

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: Cisplatin IV; Drug: Vinorelbine; Radiation: Radiotherapy

• Registration Number: NCT01029678
• Lead Sponsor: University Hospital, Limoges

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-09
• Study First Submitted QC: 2009-12-09
• Study First Posted: 2009-12-10
• Study Start: 2010-01
• Primary Completion: 2015-01
• Study Completion: 2016-06
• Status Verified: 2018-01
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental	Cisplatin IV	-
experimental	Radiotherapy	-
experimental	Vinorelbine	-

Primary Outcome Measures

Name	Time	Method
Acute toxicity	during treatment and during the 4 weeks following the end of treatment

Secondary Outcome Measures

Name	Time	Method
Late toxicity	6 months after the end of the treatment
Overall response rate	4 weeks after treatment

Trial Locations

Locations (5)

CHU Reims; 🇫🇷 Reims, France

CH de Meaux; 🇫🇷 Meaux, France

CHU Brest; 🇫🇷 Brest, France

Département de Pathologie Respiratoire du CHU de Limoges; 🇫🇷 Limoges, France

Centre Hospitalier GAP; 🇫🇷 GAP, France