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Randomized Study of Cisplatin-Etoposide Versus an Etoposide Regimen Without Cisplatin in Extensive Small-Cell Lung Cancer
Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase III | Treatment | Active | 18 and over | ELCWP 01994
NCT00658580 |
Trial Description
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 Criteria: - 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
Exclusion Criteria: - 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
- 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
Trial Contact Information
Trial Lead Organizations/Sponsors European Lung Cancer Working Party | Jean Paul Sculier | | Study Chair |
| Thierry Berghmans, MD | | Ph: 32-2-541-3111 |
Trial Sites
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| Belgium |
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Brussels |
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| | | | | | | | Institut Jules Bordet |
| | | Jean Paul Sculier | Principal Investigator |
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| France |
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Lille |
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| | | | Centre Hospitalier Regional et Universitaire de Lille |
| | | Arnaud Scherpereel, MD, PhD |
Ph: 33-32-044-4998 |
| | | Arnaud Scherpereel, MD, PhD | Principal Investigator |
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| Greece |
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Athens |
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| | | | Saint Savas Cancer Hospital of Athens |
| | | Anna P. Efremidis | Principal Investigator |
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| Spain |
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Valencia |
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| | | | Hospital de Sagunto |
| | | Vicente Giner, MD | Principal Investigator |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00658580
Information obtained from ClinicalTrials.gov on March 18, 2009 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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