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

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ClinicalTrials.gov Identifier: NCT00658580
Recruitment Status : Completed
First Posted : April 15, 2008
Last Update Posted : February 12, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Small Cell Lung Carcinoma, Extensive Disease Drug: Cisplatin + etoposide Drug: Epirubicin + ifosfamide + etoposide Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 361 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2000
Actual Primary Completion Date : December 2013
Actual Study Completion Date : February 2015


Arm Intervention/treatment
Active Comparator: A
Every 3 weeks intravenous cisplatin plus etoposide
Drug: Cisplatin + etoposide

Cisplatin 90 mg/m² day 1, every 3 weeks

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


Experimental: B
Every 3 weeks intravenous epirubicin plus ifosfamide plus etoposide
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





Primary Outcome Measures :
  1. Survival [ Time Frame: Survival will be dated from the day of randomisation until death or last follow up ]

Secondary Outcome Measures :
  1. Response rate [ Time Frame: Every 3 cycles of chemotherapy ]
  2. Toxicity [ Time Frame: After every cycle of chemotherapy ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00658580


Locations
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Belgium
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
Brussels, Belgium, 1000
France
Department of Pneumology CHRU Lille
Lille, France
Greece
Hellenic Cancer Institute - St Savas Oncology Hospital
Athens, Greece
Spain
Medical Oncology Hospital de Sagunto
Valencia, Spain
Sponsors and Collaborators
European Lung Cancer Working Party
Investigators
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Study Chair: Jean-Paul Sculier, MD, PhD European Lung Cancer Working Party

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: European Lung Cancer Working Party
ClinicalTrials.gov Identifier: NCT00658580     History of Changes
Other Study ID Numbers: ELCWP 01994
First Posted: April 15, 2008    Key Record Dates
Last Update Posted: February 12, 2015
Last Verified: February 2015
Keywords provided by European Lung Cancer Working Party:
Small cell lung carcinoma
Chemotherapy
Phase III randomised study
Additional relevant MeSH terms:
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Small Cell Lung Carcinoma
Lung Neoplasms
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Cisplatin
Etoposide
Etoposide phosphate
Epirubicin
Ifosfamide
Isophosphamide mustard
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents, Alkylating
Alkylating Agents