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

Primary Purpose

Small Cell Lung Carcinoma, Extensive Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cisplatin + etoposide
Epirubicin + ifosfamide + etoposide
Sponsored by
European Lung Cancer Working Party
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Carcinoma, Extensive Disease focused on measuring Small cell lung carcinoma, Chemotherapy, Phase III randomised study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
  • Department of Pneumology CHRU Lille
  • Hellenic Cancer Institute - St Savas Oncology Hospital
  • Medical Oncology Hospital de Sagunto

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A

B

Arm Description

Every 3 weeks intravenous cisplatin plus etoposide

Every 3 weeks intravenous epirubicin plus ifosfamide plus etoposide

Outcomes

Primary Outcome Measures

Survival

Secondary Outcome Measures

Response rate
Toxicity

Full Information

First Posted
April 11, 2008
Last Updated
February 11, 2015
Sponsor
European Lung Cancer Working Party
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1. Study Identification

Unique Protocol Identification Number
NCT00658580
Brief Title
Randomized Study of Cisplatin-Etoposide Versus an Etoposide Regimen Without Cisplatin in Extensive Small-Cell Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
April 2000 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Lung Cancer Working Party

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Carcinoma, Extensive Disease
Keywords
Small cell lung carcinoma, Chemotherapy, Phase III randomised study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
361 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Every 3 weeks intravenous cisplatin plus etoposide
Arm Title
B
Arm Type
Experimental
Arm Description
Every 3 weeks intravenous epirubicin plus ifosfamide plus etoposide
Intervention Type
Drug
Intervention Name(s)
Cisplatin + etoposide
Intervention Description
Cisplatin 90 mg/m² day 1, every 3 weeks Etoposide 100 mg/m² days 1-3, every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Epirubicin + ifosfamide + etoposide
Intervention Description
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 Measure Information:
Title
Survival
Time Frame
Survival will be dated from the day of randomisation until death or last follow up
Secondary Outcome Measure Information:
Title
Response rate
Time Frame
Every 3 cycles of chemotherapy
Title
Toxicity
Time Frame
After every cycle of chemotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Paul Sculier, MD, PhD
Organizational Affiliation
European Lung Cancer Working Party
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Department of Pneumology CHRU Lille
City
Lille
Country
France
Facility Name
Hellenic Cancer Institute - St Savas Oncology Hospital
City
Athens
Country
Greece
Facility Name
Medical Oncology Hospital de Sagunto
City
Valencia
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
28975084
Citation
Berghmans T, Scherpereel A, Meert AP, Giner V, Lecomte J, Lafitte JJ, Leclercq N, Paesmans M, Sculier JP; European Lung Cancer Working Party (ELCWP). 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. Front Oncol. 2017 Sep 19;7:217. doi: 10.3389/fonc.2017.00217. eCollection 2017.
Results Reference
derived
Links:
URL
http://www.e-cancer.fr
Description
Trials registry of the French National Cancer Institute

Learn more about this trial

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

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