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

European Lung Cancer Working Party

Status and phase: Terminated; Phase 2

Conditions: Non Small Cell Lung Carcinoma

Treatments: Procedure: Lobectomy followed by concomitant mediastinal chemoradiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00661011

ELCWP 01061

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

A

Experimental group

Description:

Lobectomy followed by mediastinal concomitant chemoradiotherapy

Treatment:

Procedure: Lobectomy followed by concomitant mediastinal chemoradiotherapy