Randomized Study of Cisplatin-Etoposide Versus an Etoposide Regimen Without Cisplatin in Extensive Small-Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Phase III Randomized Study Comparing A Chemotherapy With Cisplatin And Etoposide To A Etoposide Regimen Without Cisplatin For Patients With Extensive Small-Cell Lung Cancer

Conditions
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Small Cell Lung Carcinoma, Extensive Disease

Intervention / Treatment
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* Drug: Cisplatin + etoposide
* Drug: Epirubicin + ifosfamide + etoposide


Participation Criteria
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Eligibility Criteria
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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 Informed consent 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Every 3 weeks intravenous cisplatin plus etoposide | Drug: Cisplatin + etoposide<br>* Cisplatin 90 mg/m² day 1, every 3 weeks Etoposide 100 mg/m² days 1-3, every 3 weeks<br>|
| Experimental: B<br>Every 3 weeks intravenous epirubicin plus ifosfamide plus etoposide | Drug: Epirubicin + ifosfamide + etoposide<br>* Epirubicin 60 mg/m² day 1, every 3 weeks Ifosfamide (+ uromitexan) 1.5 g/m² days 1-3, every 3 weeks Etoposide 100 mg/m² days 1-3, every 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | Survival will be dated from the day of randomisation until death or last follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | Every 3 cycles of chemotherapy | 
| Toxicity |  | After every cycle of chemotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Small cell lung carcinoma, Chemotherapy, Phase III randomised study