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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

361 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-04-30

Study Completion Date

2015-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Small Cell Lung Carcinoma, Extensive Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Every 3 weeks intravenous cisplatin plus etoposide

Group Type ACTIVE_COMPARATOR

Cisplatin + etoposide

Intervention Type DRUG

Cisplatin 90 mg/m² day 1, every 3 weeks

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

B

Every 3 weeks intravenous epirubicin plus ifosfamide plus etoposide

Group Type EXPERIMENTAL

Epirubicin + ifosfamide + etoposide

Intervention Type DRUG

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

Interventions

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Cisplatin + etoposide

Cisplatin 90 mg/m² day 1, every 3 weeks

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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No