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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Neoplasms

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate in each arm measured according to RECIST criteria

Outcome Time Frame:

Throughout the whole study

Safety Issue:

No

Principal Investigator

José Mª Taboada

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

Spain: Spanish Agency of Medicines

Study ID:

TAX_ES1_209

NCT ID:

NCT00258739

Start Date:

October 2001

Completion Date:

Related Keywords:

  • Lung Neoplasms
  • Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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