Lobectomy and Mediastinal Radiochemotherapy in Unresectable Stage III Non-Small Cell Lung Cancer Responding to Induction Chemotherapy

Study Overview
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Brief Summary
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The purpose of this study is 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.

Official Title
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A Phase II Study Assessing the Curative Effect of the Combination of Lobectomy Followed by Mediastinal Concomitant Radiochemotherapy in Patients With Locally Advanced Unresectable Stage III Non-small Cell Lung Cancer Responding to Induction Chemotherapy

Conditions
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Non Small Cell Lung Carcinoma

Intervention / Treatment
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* Procedure: Lobectomy followed by concomitant mediastinal chemoradiotherapy


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Prior treatment with radiotherapy or surgery Karnofsky PS < 60 Functional or anatomical contra-indication to mediastinal radiotherapy Functional or anatomical contra-indication to surgical lobectomy A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or cured malignant tumour (more than 5 year disease-free interval) Malignant pleural or pericardial effusion Neutrophils < 2,000/mm³ Platelet cells < 100,000/mm3 Serum bilirubin > 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

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Lobectomy followed by mediastinal concomitant chemoradiotherapy | Procedure: Lobectomy followed by concomitant mediastinal chemoradiotherapy<br>* Lobectomy Radiotherapy 66 Gy in 2 Gy/ fraction, 5 fractions/wk Chemotherapy Cisplatin 60 mg/m² on days 1 and 22 and Vinorelbine 15 mg/m² on days 1, 8, 22 and 29<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | Survival will be dated from the day of registration until death or last follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative mortality and morbidity |  | To be observed during the 30 days following the surgical procedure | 
| Local control rate |  | After completion of treatment | 
| Toxicity |  | After each course of chemotherapy and at the end of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-small cell lung carcinoma, Concomitant radiochemotherapy, Cisplatin, Vinorelbine, Radiotherapy, Chemotherapy, Unresectable stage III non-small cell lung carcinoma, Surgery, Unresectable stage III non-small cell lung carcinoma not suitable for radical radiotherapy after objective response to induction chemotherapy