NCT00658580

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
361

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2000

Longer than P75 for phase_3

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2000

Completed
8 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 15, 2008

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 12, 2015

Status Verified

February 1, 2015

Enrollment Period

13.7 years

First QC Date

April 11, 2008

Last Update Submit

February 11, 2015

Conditions

Small Cell Lung Carcinoma, Extensive Disease

Keywords

Small cell lung carcinomaChemotherapyPhase III randomised study

Outcome Measures

Primary Outcomes (1)

  • Survival

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

Secondary Outcomes (2)

  • Response rate

    Every 3 cycles of chemotherapy

  • Toxicity

    After every cycle of chemotherapy

Study Arms (2)

A

ACTIVE COMPARATOR

Every 3 weeks intravenous cisplatin plus etoposide

Drug: Cisplatin + etoposide

B

EXPERIMENTAL

Every 3 weeks intravenous epirubicin plus ifosfamide plus etoposide

Drug: Epirubicin + ifosfamide + etoposide

Interventions

Cisplatin + etoposideDRUG

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

A
Epirubicin + ifosfamide + etoposideDRUG

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

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet

Brussels, 1000, Belgium

Location

Department of Pneumology CHRU Lille

Lille, France

Location

Hellenic Cancer Institute - St Savas Oncology Hospital

Athens, Greece

Location

Medical Oncology Hospital de Sagunto

Valencia, Spain

Location

Related Publications (1)

  • 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.

    PMID: 28975084DERIVED

Related Links

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

PE regimenEpirubicinIfosfamideEtoposide

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

DoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesCyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesGlucosides

Study Officials

  • Jean-Paul Sculier, MD, PhD

    European Lung Cancer Working Party

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2008

First Posted

April 15, 2008

Study Start

April 1, 2000

Primary Completion

December 1, 2013

Study Completion

February 1, 2015

Last Updated

February 12, 2015

Record last verified: 2015-02

Locations

FR(1)BE(1)ES(1)GR(1)