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

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Lung Cancer Working Party
• Treatments: Cisplatin; Epirubicin; Etoposide; Etoposide phosphate; Ifosfamide; Isophosphamide mustard

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