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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00658580

Enrollment

361

Registered

2008-04-15

Start date

2000-04-30

Completion date

2015-02-28

Last updated

2015-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Cell Lung Carcinoma, Extensive Disease

Keywords

Small cell lung carcinoma, Chemotherapy, Phase III randomised study

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.

Interventions

DRUGCisplatin + etoposide

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

DRUGEpirubicin + 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Response rate	Every 3 cycles of chemotherapy
Toxicity	After every cycle of chemotherapy

Countries

Belgium, France, Greece, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026