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

February 14, 2008
January 29, 2013
February 2004
March 2009   (final data collection date for primary outcome measure)
Survival [ Time Frame: Survival will be dated from the first day of registration until death or last follow up ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00622349 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Randomised Study Comparing Three Chemotherapy Regimens in Non-small Cell Lung Cancer
A Phase III Randomised Study Comparing Three Combination Chemotherapy Regimens in Patients With Non Pre-treated Advanced Non-small Cell Lung Cancer

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Non-Small-Cell Lung
  • 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
  • Experimental: A
    Intervention: Drug: Cisplatin, Ifosfamide, Gemcitabine
  • Active Comparator: B
    Intervention: Drug: Ifosfamide, Gemcitabine
  • Experimental: C
    Intervention: Drug: Cisplatin, docetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
707
December 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Greece,   Spain
 
NCT00622349
ELCWP-01041
Yes
European Lung Cancer Working Party
European Lung Cancer Working Party
Not Provided
Study Chair: Jean-Paul Sculier, MD, PhD European Lung Cancer Working Party
European Lung Cancer Working Party
January 2013

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