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

Information source: European Lung Cancer Working Party
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Small Cell Lung Carcinoma, Extensive Disease

Intervention: Cisplatin + etoposide (Drug); Epirubicin + ifosfamide + etoposide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: European Lung Cancer Working Party

Official(s) and/or principal investigator(s):
Jean-Paul Sculier, MD, PhD, Study Chair, Affiliation: European Lung Cancer Working Party

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Survival

Secondary outcome:

Response rate

Toxicity

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet, Brussels 1000, Belgium

Department of Pneumology CHRU Lille, Lille, France

Hellenic Cancer Institute - St Savas Oncology Hospital, Athens, Greece

Medical Oncology Hospital de Sagunto, Valencia, Spain

Additional Information

Click here for more information on the protocol

Trials registry of the French National Cancer Institute

Starting date: April 2000
Last updated: February 11, 2015

Page last updated: August 23, 2015

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