Small Cell Lung Carcinoma, Extensive Disease Clinical Trial
Official title:
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
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.
| Status | Completed |
| Enrollment | 361 |
| Est. completion date | February 2015 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet | Brussels | |
| France | Department of Pneumology CHRU Lille | Lille | |
| Greece | Hellenic Cancer Institute - St Savas Oncology Hospital | Athens | |
| Spain | Medical Oncology Hospital de Sagunto | Valencia |
| Lead Sponsor | Collaborator |
|---|---|
| European Lung Cancer Working Party |
Belgium, France, Greece, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Survival | Survival will be dated from the day of randomisation until death or last follow up | Yes | |
| Secondary | Response rate | Every 3 cycles of chemotherapy | No | |
| Secondary | Toxicity | After every cycle of chemotherapy | No |