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Docetaxel in Non Small Cell Lung Cancer (NSCLC)

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: NCT00258739
Recruitment Status : Completed
First Posted : November 28, 2005
Last Update Posted : December 7, 2009
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE November 23, 2005
First Posted Date  ICMJE November 28, 2005
Last Update Posted Date December 7, 2009
Study Start Date  ICMJE October 2001
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2008)
Response rate in each arm measured according to RECIST criteria [ Time Frame: Throughout the whole study ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00258739 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2008)
  • Percentage of local-regional control within a year [ Time Frame: Throughout the first year ]
  • Time to progression defined as the period of time elapsed between the randomization date and the progression or death date [ Time Frame: Throughout the whole study ]
  • Toxicity measured by CALGB criteria and RTOG/EORTC criteria [ Time Frame: Throughout the whole study ]
  • Global surveillance measured as the period of time elapsed between randomization and death date. [ Time Frame: Throughout the whole study duration ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Docetaxel in Non Small Cell Lung Cancer (NSCLC)
Official Title  ICMJE A Phase II, Randomized Study With Docetaxel-gemcitabine Followed by Radiotherapy vs Concomitant Treatment (Radiotherapy and Carboplatine-docetaxel) Followed by Docetaxel-gemcitabine Versus Docetaxel-gemcitabine Followed by Concomitant Treatment (Radiotherapy and Carboplatine-docetaxel) in Stage III NSCLC
Brief Summary

Primary objective:

  • To classify the 2 study groups, according to the tumoral response.

Secondary objectives:

  • To evaluate the percentage of focused control per year.
  • To calculate the time until progression.
  • To evaluate the safety profile.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Neoplasms
Intervention  ICMJE
  • Drug: Docetaxel + carboplatin + radiotherapy + docetaxel + gemcitabine
    Docetaxel 20 mg/m²/week with carboplatin AUC 2/week and concomitant radiotherapy up to 60 Gy. Further on, 2 Docetaxel cycles and gemcitabine according to arm 2.
  • Other: Docetaxel + gemcitabine + carboplatin + radiotherapy
    Docetaxel 40 mg/ m² days 1, 8, 21 and 28 with gemcitabine 1200 mg/ m² days 1, 8, 21 and 28 followed by concomitant treatment with docetaxel 20 mg/m²/week with carboplatin AUC 2/week and concomitant radiotherapy up to 60 Gy (2 Gy/day, 5 days per week and for 6 weeks).
Study Arms  ICMJE
  • Experimental: 1
    Concomitant radiotherapy and carboplatin-docetaxel followed by docetaxel-gemcitabine
    Intervention: Drug: Docetaxel + carboplatin + radiotherapy + docetaxel + gemcitabine
  • Experimental: 2
    docetaxel-gemcitabine followed by concomitant radiotherapy with carboplatin-docetaxel
    Intervention: Other: Docetaxel + gemcitabine + carboplatin + radiotherapy
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: December 21, 2006)
140
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Non small cell lung cancer confirmed by histology or by cytology.
  • IIIB stage, except if existing pleural discharge, upper cava vein syndrome or supraclavicular affectation
  • General stage 0-1 at the ECOG scale
  • Loss of weight less than 5% in the 3 previous months from diagnose.
  • Pulmonary function and gasometry results: FEV1 > 30% or 1 l, DLCO (diffusing capacity of the lung for carbon monoxide) > 30%, PCO2 < 45 mmHg and PO2 > 60 mmHg.
  • Normal medullar function (hemoglobin > 11 g/dl, total WBC > 1,5 x 10^9/l, platelets > 100 x 10^9/l)
  • Appropriate renal and hepatic functions
  • CTScan
  • Anticonceptive method
  • Available laboratory test (maximum 1 month before)

Exclusion criteria:

  • Pleural discharge, upper cava vein syndrome or supraclavicular affectation.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00258739
Other Study ID Numbers  ICMJE TAX_ES1_209
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical Affairs Study Director, sanofi-aventis
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: José Mª Taboada Sanofi
PRS Account Sanofi
Verification Date December 2009

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