Status:
COMPLETED
Randomised Study Comparing Three Chemotherapy Regimens in Non-small Cell Lung Cancer
Lead Sponsor:
European Lung Cancer Working Party
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if cisplatin-based chemotherapy, cisplatin-gemcitabine-ifosfamide or cisplatin-docetaxel, will improve survival in comparison to the combination gemcitabine-i...
Eligibility Criteria
Inclusion
- Histological or cytological diagnosis of non-small cell lung cancer
- Advanced (unresectable or functionally inoperable) stage III or stage IV disease
- Availability for participating in the detailed follow-up of the protocol
- Presence of an evaluable or measurable lesion
- Informed consent
Exclusion
- Prior treatment with chemotherapy
- Operable patient with resectable tumour
- 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 and cured malignant tumour (more than 5-year disease free interval)
- Polynuclear cells \< 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
- Perception hypoacousia
- Peripheral neuropathy
- Recent myocardial infarction (less than 3 months prior to date of diagnosis)
- Congestive cardiac failure requiring medical therapy or uncontrolled cardiac arrhythmia
- Uncontrolled infectious disease
- Serious medical or psychological factors which may prevent adherence to the treatment schedule
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
707 Patients enrolled
Trial Details
Trial ID
NCT00622349
Start Date
February 1 2004
End Date
December 1 2009
Last Update
January 30 2013
Active Locations (4)
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1
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
Brussels, Belgium, 1000
2
Pneumology department of CHU Lille
Lille, France
3
Hellenic Cancer Institute - St Savas Oncology Hospital
Athens, Greece
4
Medical Oncology Hospital de Sagunto
Valencia, Spain