Status:
COMPLETED
Randomized Study of Cisplatin-Etoposide Versus an Etoposide Regimen Without Cisplatin in Extensive Small-Cell Lung Cancer
Lead Sponsor:
European Lung Cancer Working Party
Conditions:
Small Cell Lung Carcinoma, Extensive Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if a cisplatin-etoposide regimen improves survival in comparison to a regimen containing etoposide and without platinum derivative.
Eligibility Criteria
Inclusion
- Histological or cytological diagnosis of small-cell lung cancer
- Extensive disease (i.e. a disease with distant metastases or that cannot be included in a single irradiation field incorporating primary tumour, mediastinum and supraclavicular lymph node(s))
- 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, radiotherapy or surgery
- Performance status \< 60 on the Karnofsky scale
- A history of prior malignant tumor, except non-melanoma skin cancer or in situ carcinoma of the cervix or a cured cancer (defined as a disease-free interval \> 5 years)
- White blood cells \< 4000/mm3
- Platelets \< 100000/mm3
- Serum bilirubin \> 1.5 mg/100 ml
- Serum creatinine \> 1.3 mg/100 ml and creatinine clearance \<60 ml/min
- Recent myocardial infarction (less than 3 months prior to date of diagnosis)
- Congestive cardiac failure or cardiac arrhythmia uncontrolled by medical treatment
- Uncontrolled infectious disease
- Serious medical or psychological factors which may prevent adherence to the treatment schedule
Key Trial Info
Start Date :
April 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
361 Patients enrolled
Trial Details
Trial ID
NCT00658580
Start Date
April 1 2000
End Date
February 1 2015
Last Update
February 12 2015
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
Brussels, Belgium, 1000
2
Department of Pneumology CHRU Lille
Lille, France
3
Hellenic Cancer Institute - St Savas Oncology Hospital
Athens, Greece
4
Medical Oncology Hospital de Sagunto
Valencia, Spain