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OpenTrials
Completed

NCT Number: NCT00258739

Docetaxel in Non Small Cell Lung Cancer (NSCLC)

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.

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Key information

Conditions

Lung Neoplasms Lung Diseases Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sanofi-Aventis

Barcelona, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Docetaxel + carboplatin + radiotherapy + docetaxel + gemcitabine

Drug

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.

Docetaxel + gemcitabine + carboplatin + radiotherapy

Other

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 outcomes

  1. Response rate in each arm measured according to RECIST criteria

    Time frame: Throughout the whole study

Secondary outcomes

  1. Percentage of local-regional control within a year

    Time frame: Throughout the first year

  2. 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

  3. Toxicity measured by CALGB criteria and RTOG/EORTC criteria

    Time frame: Throughout the whole study

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

    Time frame: Throughout the whole study duration

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2007
First posted
Nov 28, 2005
Registry last updated
Dec 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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