Lobectomy and Mediastinal Radiochemotherapy in Unresectable Stage III Non-Small Cell Lung Cancer Responding to Induction Chemotherapy
- Conditions
- Non Small Cell Lung Carcinoma
- Interventions
- Procedure: Lobectomy followed by concomitant mediastinal chemoradiotherapy
- Registration Number
- NCT00661011
- Lead Sponsor
- European Lung Cancer Working Party
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 75
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A Lobectomy followed by concomitant mediastinal chemoradiotherapy Lobectomy followed by mediastinal concomitant chemoradiotherapy
- Primary Outcome Measures
Name Time Method Survival Survival will be dated from the day of registration until death or last follow up
- Secondary Outcome Measures
Name Time Method Local control rate After completion of treatment Toxicity After each course of chemotherapy and at the end of treatment Operative mortality and morbidity To be observed during the 30 days following the surgical procedure
Trial Locations
- Locations (12)
Department of Pneumology Hospital Ixelles-Molière
🇧🇪Brussels, Belgium
Department of Pneumology Centre Hospitalier de Mouscron
🇧🇪Mouscron, Belgium
CH Peltzer-La Tourelle
🇧🇪Verviers, Belgium
Medical Oncology Hospital de Sagunto
🇪🇸Valencia, Spain
Department of Pneumology RHMS Hôpital de la Madeleine
🇧🇪Ath, Belgium
Department of Pneumology CHR St Joseph-Warquignies
🇧🇪Boussu, Belgium
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
🇧🇪Brussels, Belgium
Department of Pneumology CHU Charleroi
🇧🇪Charleroi, Belgium
Department of Pneumology Hôpital Saint-Joseph
🇧🇪Gilly, Belgium
Hôpital Ambroise Paré
🇧🇪Mons, Belgium
Hôpital Vésale - Montigny-le-Tilleul
🇧🇪Montigny-le-Tilleul, Belgium
Medical Oncology St Savas Hospital
🇬🇷Athens, Greece