Trial | NCT00658580  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    361
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.
Study Started
Apr 30
2000
Primary Completion
Dec 31
2013
Study Completion
Feb 28
2015
Last Update
Feb 12
2015
Estimate

Drug Cisplatin + etoposide

Cisplatin 90 mg/m² day 1, every 3 weeks Etoposide 100 mg/m² days 1-3, every 3 weeks

Drug Epirubicin + ifosfamide + etoposide

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

A Active Comparator

Every 3 weeks intravenous cisplatin plus etoposide

B Experimental

Every 3 weeks intravenous epirubicin plus ifosfamide plus etoposide

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
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
No Results Posted