Status:
TERMINATED
Lobectomy and Mediastinal Radiochemotherapy in Unresectable Stage III Non-Small Cell Lung Cancer Responding to Induction Chemotherapy
Lead Sponsor:
European Lung Cancer Working Party
Conditions:
Non Small Cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00661011
Start Date
January 1 2007
End Date
June 1 2014
Last Update
February 12 2015
Active Locations (12)
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1
Department of Pneumology RHMS Hôpital de la Madeleine
Ath, Belgium, 7800
2
Department of Pneumology CHR St Joseph-Warquignies
Boussu, Belgium, 7360
3
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
Brussels, Belgium, 1000
4
Department of Pneumology Hospital Ixelles-Molière
Brussels, Belgium