NCT00258739

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 28, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Last Updated

December 7, 2009

Status Verified

December 1, 2009

Enrollment Period

5.9 years

First QC Date

November 23, 2005

Last Update Submit

December 4, 2009

Conditions

Lung Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Response rate in each arm measured according to RECIST criteria

    Throughout the whole study

Secondary Outcomes (4)

  • Percentage of local-regional control within a year

    Throughout the first year

  • Time to progression defined as the period of time elapsed between the randomization date and the progression or death date

    Throughout the whole study

  • Toxicity measured by CALGB criteria and RTOG/EORTC criteria

    Throughout the whole study

  • Global surveillance measured as the period of time elapsed between randomization and death date.

    Throughout the whole study duration

Study Arms (2)

1

EXPERIMENTAL

Concomitant radiotherapy and carboplatin-docetaxel followed by docetaxel-gemcitabine

Drug: Docetaxel + carboplatin + radiotherapy + docetaxel + gemcitabine

2

EXPERIMENTAL

docetaxel-gemcitabine followed by concomitant radiotherapy with carboplatin-docetaxel

Other: Docetaxel + gemcitabine + carboplatin + radiotherapy

Interventions

Docetaxel + carboplatin + radiotherapy + docetaxel + gemcitabineDRUG

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.

1
Docetaxel + gemcitabine + carboplatin + radiotherapyOTHER

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).

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Barcelona, Spain

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

DocetaxelCarboplatinRadiotherapyGemcitabine

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination ComplexesTherapeuticsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • José Mª Taboada

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 23, 2005

First Posted

November 28, 2005

Study Start

October 1, 2001

Primary Completion

September 1, 2007

Last Updated

December 7, 2009

Record last verified: 2009-12

Locations

ES(1)