Back to resultsDocetaxel in Non Small Cell Lung Cancer (NSCLC)
Primary Purpose
Lung Neoplasms
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Docetaxel + carboplatin + radiotherapy + docetaxel + gemcitabine
Docetaxel + gemcitabine + carboplatin + radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Lung Neoplasms
Eligibility Criteria
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.
Sites / Locations
- Sanofi-Aventis
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Concomitant radiotherapy and carboplatin-docetaxel followed by docetaxel-gemcitabine
docetaxel-gemcitabine followed by concomitant radiotherapy with carboplatin-docetaxel
Outcomes
Primary Outcome Measures
Response rate in each arm measured according to RECIST criteria
Secondary Outcome Measures
Percentage of local-regional control within a year
Time to progression defined as the period of time elapsed between the randomization date and the progression or death date
Toxicity measured by CALGB criteria and RTOG/EORTC criteria
Global surveillance measured as the period of time elapsed between randomization and death date.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00258739
Brief Title
Docetaxel in Non Small Cell Lung Cancer (NSCLC)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Concomitant radiotherapy and carboplatin-docetaxel followed by docetaxel-gemcitabine
Arm Title
2
Arm Type
Experimental
Arm Description
docetaxel-gemcitabine followed by concomitant radiotherapy with carboplatin-docetaxel
Intervention Type
Drug
Intervention Name(s)
Docetaxel + carboplatin + radiotherapy + docetaxel + gemcitabine
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Docetaxel + gemcitabine + carboplatin + radiotherapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
Response rate in each arm measured according to RECIST criteria
Time Frame
Throughout the whole study
Secondary Outcome Measure Information:
Title
Percentage of local-regional control within a year
Time Frame
Throughout the first year
Title
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
Title
Toxicity measured by CALGB criteria and RTOG/EORTC criteria
Time Frame
Throughout the whole study
Title
Global surveillance measured as the period of time elapsed between randomization and death date.
Time Frame
Throughout the whole study duration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Mª Taboada
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Barcelona
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Docetaxel in Non Small Cell Lung Cancer (NSCLC)
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