EUCTR2006-004726-91-FR
Active, not recruiting
Phase 1
A phase III randomised study comparing concomitant radiochemotherapy with cisplatin and docetaxel as induction versus consolidation treatment in patients with locally advanced unresectable non-small cell lung cancer
CHRU de Lille0 sites246 target enrollmentMarch 19, 2009
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- nresectable non metastatic stage III non small cell lung carcinoma eligible for concomitant radiochemotherapy
- Sponsor
- CHRU de Lille
- Enrollment
- 246
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Men or women aged \= 18 years old
- •\- Histological or cytological diagnosis of non\-small cell carcinoma of the lung
- •\- Initially unresectable non\-metastatic stage III disease
- •\- Availability for participating in the detailed follow\-up of the protocol
- •\- Presence of an evaluable or measurable lesion
- •\- Written informed consent
- •\- No functional or anatomical contraindication to chest irradiation
- •\- Irradiation technically possible
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
Exclusion Criteria
- •\- Prior treatment with chemotherapy, radiotherapy or surgery
- •\- Performance status \< 60 on the Karnofsky scale
- •\- 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)
- •\- Neutrophils \< 2,000/mm³
- •\- Platelet cells \< 100,000/mm3
- •\- Serum bilirubin \> 1\.5 mg/100 ml
- •\- Hepatic disease contra\-indicating the administration of docetaxel and/or GOT or GPT \= 2\.5x the normal value and/or alkaline phosphatase \= 5x the normal value
- •\- 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) or uncontrolled angina pectoris
- •\- Congestive cardiac failure or cardiac arrhythmia requiring medical treatment
Outcomes
Primary Outcomes
Not specified
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