EUCTR2006-004713-18-BE
Active, not recruiting
Not Applicable
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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- European Lung Cancer Working Party
- Enrollment
- 75
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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:
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
Outcomes
Primary Outcomes
Not specified
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