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

European Lung Cancer Working Party

Status and phase

Completed

Phase 3

Conditions

Small Cell Lung Carcinoma, Extensive Disease

Treatments

Drug: Cisplatin + etoposide

Drug: Epirubicin + ifosfamide + etoposide

Study type

Interventional

Funder types

Other

Identifiers

NCT00658580

ELCWP 01994

Details and patient eligibility

About

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.

Enrollment

361 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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