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Docetaxel in Non Small Cell Lung Cancer (NSCLC)

NCT00258739 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2009-12-07

No results posted yet for this study

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.

Conditions

  • Lung Neoplasms

Interventions

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).

Sponsors & Collaborators

Principal Investigators

  • José Mª Taboada · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-10-31
Primary Completion
2007-09-30

Countries

  • Spain

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00258739 on ClinicalTrials.gov