Randomised Study Comparing Three Chemotherapy Regimens in Non-small Cell Lung Cancer
NCT ID: NCT00622349
Last Updated: 2013-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
707 participants
INTERVENTIONAL
2004-02-29
2009-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Standard Therapy Given With or Without Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer
NCT00003240
Randomized Phase III-Study in Stage IIIb and IV Non-Small-Cell Lung Cancer. Sequential Single-Agent vs. Double-Agent vs. Triple-Agent Therapy.
NCT00148395
Comparison of Two Combination Chemotherapy Regimens in Treating Non-small Cell Lung Cancer
NCT00006004
Chemotherapy/Radiotherapy Versus Concomitant Chemotherapy Followed by Radiotherapy in Stage IIIB Non-small Cell Lung Cancer
NCT01652820
Survival Study of Docetaxel and Carboplatin as Neo-Adjuvant Vs Adjuvant Chemotherapy in Early Stage NSLC
NCT00321334
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A
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
B
Ifosfamide, Gemcitabine
Ifosfamide 3g/m² day 1 (+ uromitexan rescue) Gemcitabine 1 g/m² days 1 and 8 Cycles every 3 weeks
C
Cisplatin, docetaxel
Cisplatin 50 mg/m² day 1 Docetaxel 75 mg/m² day 1 Cycles every 3 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Ifosfamide, Gemcitabine
Ifosfamide 3g/m² day 1 (+ uromitexan rescue) Gemcitabine 1 g/m² days 1 and 8 Cycles every 3 weeks
Cisplatin, docetaxel
Cisplatin 50 mg/m² day 1 Docetaxel 75 mg/m² day 1 Cycles every 3 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
European Lung Cancer Working Party
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jean-Paul Sculier, MD, PhD
Role: STUDY_CHAIR
European Lung Cancer Working Party
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
Brussels, , Belgium
Pneumology department of CHU Lille
Lille, , France
Hellenic Cancer Institute - St Savas Oncology Hospital
Athens, , Greece
Medical Oncology Hospital de Sagunto
Valencia, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Click here for more information on the protocol
Trial registry of the French National Cancer Institute
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ELCWP-01041
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.