Randomised Study Comparing Three Chemotherapy Regimens in Non-small Cell Lung Cancer

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

European Lung Cancer Working Party

ClinicalTrials.gov Identifier:

NCT00622349

First received: February 14, 2008

Last updated: January 29, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

February 14, 2008

Last Updated Date

January 29, 2013

Start Date ^ICMJE

February 2004

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Survival [ Time Frame: Survival will be dated from the first day of registration until death or last follow up ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00622349 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Response rate [ Time Frame: Every 3 courses of chemotherapy ] [ Designated as safety issue: No ]
Toxicity [ Time Frame: After each course of chemotherapy ] [ Designated as safety issue: No ]
Activity of second-line chemotherapy [ Time Frame: Every 3 courses of chemotherapy ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Randomised Study Comparing Three Chemotherapy Regimens in Non-small Cell Lung Cancer

Official Title ^ICMJE

A Phase III Randomised Study Comparing Three Combination Chemotherapy Regimens in Patients With Non Pre-treated Advanced Non-small Cell Lung Cancer

Brief Summary

The purpose of this study is to determine if cisplatin-based chemotherapy, cisplatin-gemcitabine-ifosfamide or cisplatin-docetaxel, will improve survival in comparison to the combination gemcitabine-ifosfamide in patients with advanced NSCLC

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Carcinoma, Non-Small-Cell Lung

Intervention ^ICMJE

Drug: Cisplatin, Ifosfamide, Gemcitabine
Cisplatin 50 mg/m² day 1 Ifosfamide 3g/m² day 1 (+ uromitexan rescue) Gemcitabine 1 g/m² days 1 and 8 Cycles every 3 weeks
Drug: Ifosfamide, Gemcitabine
Ifosfamide 3g/m² day 1 (+ uromitexan rescue) Gemcitabine 1 g/m² days 1 and 8 Cycles every 3 weeks
Drug: Cisplatin, docetaxel
Cisplatin 50 mg/m² day 1 Docetaxel 75 mg/m² day 1 Cycles every 3 weeks

Study Arm (s)

Experimental: A
Intervention: Drug: Cisplatin, Ifosfamide, Gemcitabine
Active Comparator: B
Intervention: Drug: Ifosfamide, Gemcitabine
Experimental: C
Intervention: Drug: Cisplatin, docetaxel

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

707

Completion Date

December 2009

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Histological or cytological diagnosis of non-small cell lung cancer
Advanced (unresectable or functionally inoperable) stage III or stage IV disease
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
Operable patient with resectable tumour
Performance status < 60 on the Karnofsky scale
A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix and cured malignant tumour (more than 5-year disease free interval)
Polynuclear cells < 2,000/mm³
Platelet cells < 100,000/mm³
Serum bilirubin >1.5 mg/100 ml
Serum creatinine > 1.5 mg/100 ml and/or creatinine clearance < 60 ml/min
Perception hypoacousia
Peripheral neuropathy
Recent myocardial infarction (less than 3 months prior to date of diagnosis)
Congestive cardiac failure requiring medical therapy or uncontrolled cardiac arrhythmia
Uncontrolled infectious disease
Serious medical or psychological factors which may prevent adherence to the treatment schedule

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium, France, Greece, Spain

Administrative Information

NCT Number ^ICMJE

NCT00622349

Other Study ID Numbers ^ICMJE

ELCWP-01041

Has Data Monitoring Committee

Yes

Responsible Party

European Lung Cancer Working Party

Study Sponsor ^ICMJE

European Lung Cancer Working Party

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Jean-Paul Sculier, MD, PhD

European Lung Cancer Working Party

Information Provided By

European Lung Cancer Working Party

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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