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

Phase 3

Completed

• Conditions: Small Cell Lung Carcinoma, Extensive Disease
• Interventions: Drug: Cisplatin + etoposide; Drug: Epirubicin + ifosfamide + etoposide

• Registration Number: NCT00658580
• Lead Sponsor: European Lung Cancer Working Party

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-04
• Study First Submitted: 2008-04-11
• Study First Submitted QC: 2008-04-14
• Study First Posted: 2008-04-15
• Primary Completion: 2013-12
• Status Verified: 2015-02
• Study Completion: 2015-02
• Last Update Submitted: 2015-02-11
• Last Update Posted: 2015-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 361

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Cisplatin + etoposide	Every 3 weeks intravenous cisplatin plus etoposide
B	Epirubicin + ifosfamide + etoposide	Every 3 weeks intravenous epirubicin plus ifosfamide plus etoposide

Primary Outcome Measures

Name	Time	Method
Survival	Survival will be dated from the day of randomisation until death or last follow up

Secondary Outcome Measures

Name	Time	Method
Response rate	Every 3 cycles of chemotherapy
Toxicity	After every cycle of chemotherapy

Trial Locations

Locations (4)

Medical Oncology Hospital de Sagunto; 🇪🇸 Valencia, Spain

Hellenic Cancer Institute - St Savas Oncology Hospital; 🇬🇷 Athens, Greece

Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet; 🇧🇪 Brussels, Belgium

Department of Pneumology CHRU Lille; 🇫🇷 Lille, France