This phase II study aim to determine if radical radiochemotherapy on the mediastinum after lobectomy can be associated with significant long term survival in patients with initially unresectable stage III non-small cell lung cancer responding to induction chemotherapy but in which the residual disease (lung plus mediastinal diseases) is too large to be treated by radiotherapy. MedDRA version: 8.1 Level: HLT Classification code 10029105 Term: Neoplasms malignant site unspecified NEC
Conditions
Interventions
Trade Name: Vinorelbine
Pharmaceutical Form: Intravenous infusion
Other descriptive name: Vinorelbine
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number
Sponsors
European Lung Cancer Working Party
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histological or cytological diagnosis of non-small cell carcinoma of the lung - Initially stage III NSCLC - Pathologically proven N2 or N3 disease - Any response to induction chemotherapy (whatever the regimen administered) - Disease still not fully resectable (because of extensive mediastinal N disease) and not suitable for radical radiotherapy (single field) after induction chemotherapy - Lobectomy possible for the treatment of T disease - Availability for participating in the detailed follow-up of the protocol - Informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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
Exclusion criteria
Exclusion criteria: - Prior treatment with radiotherapy or surgery - Karnofsky PS 1.5 mg/100 ml - Serum creatinine > 1.5 mg/100 ml and/or creatinine clearance < 60 ml/min - Recent myocardial infarction (less than 3 months prior to date of diagnosis) - Congestive cardiac failure or cardiac arrhythmia requiring medical treatment - Uncontrolled infectious disease - Hearing loss - Symptomatic polyneuropathy - Serious medical or psychological factors which may prevent adherence to the treatment schedule
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to determine if radical radiochemotherapy on the mediastinum after lobectomy can be associated with significant long term survival in patients with initially unresectable stage III NSCLC responding to induction chemotherapy but in which the residual disease is too large to be treated by radiotherapy.;Secondary Objective: - to determine the operative mortality and morbidity - to determine the toxicity of radiochemotherapy - to determine the local control rate ;Primary end point(s): The primary endpoint of the study is the rate of patients alive without progression at 5 years | — |
Countries
Belgium
Outcome results
None listed