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Chemotherapy/Radiotherapy Versus Concomitant Chemotherapy Followed by Radiotherapy in Stage IIIB Non-small Cell Lung Cancer

NCT01652820 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-05-23

No results posted yet for this study

Summary

Randomized study in 2 arms, without any masking in patients with non small cell lung cancer, histologically or cytologically confirmed, not liable to surgery, stage IIIB or IIIA, according to the TNM classification of the American Joint Committee for cancer. In one arm will be administered concomitant radiotherapy and carboplatin-docetaxel-gemcitabine followed by docetaxel and, in the other arm will be administered docetaxel-gemcitabine followed by concurrent radiotherapy with carboplatin-docetaxel

Conditions

  • Non Small-cell Lung Cancer

Interventions

DRUG

Docetaxel 20mg/m2/week + carboplatin AUC 2/weekly - concomitant chemoradiation 2Gy/day

DRUG

Docetaxel 40mg<7m2 d1,8, 21, 28+ gemcitabine 1200mg/m2 d1,8, 21, 28 + concomitant docetaxel 20mg/m2/w+carboplatin AUC 2/w+ concomitant RDT 2Gy/d

Sponsors & Collaborators

  • Aventis Pharmaceuticals

    collaborator INDUSTRY

  • Spanish Lung Cancer Group

    lead OTHER

Principal Investigators

  • Pilar Garrido, MD · Hospital Ramon y Cajal (Madrid)

  • Rafael Rosell, MD · Germans Trias i Pujol Hospital

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
2006-07-31
Completion
2007-12-31

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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 NCT01652820 on ClinicalTrials.gov