Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00622349
Recruitment Status : Completed
First Posted : February 25, 2008
Last Update Posted : January 30, 2013
Sponsor:
Information provided by (Responsible Party):
European Lung Cancer Working Party

Tracking Information
First Submitted Date  ICMJE February 14, 2008
First Posted Date  ICMJE February 25, 2008
Last Update Posted Date January 30, 2013
Study Start Date  ICMJE February 2004
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2008)
Survival [ Time Frame: Survival will be dated from the first day of registration until death or last follow up ]
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
 (submitted: February 14, 2008)
  • Response rate [ Time Frame: Every 3 courses of chemotherapy ]
  • Toxicity [ Time Frame: After each course of chemotherapy ]
  • Activity of second-line chemotherapy [ Time Frame: Every 3 courses of chemotherapy ]
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
Intervention Model: Parallel Assignment
Masking: None (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 Arms
  • 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
Actual Enrollment  ICMJE
 (submitted: January 29, 2013)
707
Original Estimated Enrollment  ICMJE
 (submitted: February 14, 2008)
620
Actual Study Completion Date December 2009
Actual 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Greece,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00622349
Other Study ID Numbers  ICMJE ELCWP-01041
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
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
PRS Account 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