Chemotherapy/Radiotherapy Versus Concomitant Chemotherapy Followed by Radiotherapy in Stage IIIB Non-small Cell Lung Cancer
GECP0008
Randomized Phase II Trial Using Concomitant Chemoradiation Plus Induction or Consolidation Chemotherapy for Unresectable Stage III Non-small Cell Lung Cancer Patients
This date has not been verified as actual or estimated.
Primary Completion
July 2006
Actual (reported)
Study Completion
December 2007
Actual (reported)
Brief 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
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
completed
Actual enrollment (reported)
140 participants
Study completion date
December 2007
Actual (reported)
Listed locations
0 countries · 0 sites
Trial Relationships
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Related Scientific Literature
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
Study Start
October 2001
Date type not reported
This date has not been verified as actual or estimated.
Docetaxel 20 mg/m2/weekly plus carboplatin AUC 2/weekly (first, docetaxel will be administered and after that, carboplatin will be administered) and concomitant chemoradiation (total dose of 60 Gy: 2 Gy/day, 5 days(week for 6 weeks)
C) Docetax+ gemcit +concom. docetax + carbopl. + RDT concom
EXPERIMENTAL
Docetaxel 40 mg/ m2 days 1, 8, 21 y 28 plus gemcitabine 1200 mg/ m2 days 1, 8, 21 y 28 followed by concomitant treatment Docetaxel 20 mg/m2/week plus carboplatin AUC 2/weekly and concomitant chemoradiation total dose of 60 Gy: 2 Gy/day, 5 days(week for 6 weeks)
Garrido P, Rosell R, Arellano A, Andreu F, Domine M, Perez-Casas A, Cardenal F, Arnaiz Mdel M, Moran T, Morera R, Isla D, Valencia J, Cobo M, Delgado R, Garcia-Gomez R, Calvo F, Zamora J, Ramos A, Massuti B. Randomized phase II trial of non-platinum induction or consolidation chemotherapy plus concomitant chemoradiation in stage III NSCLC patients: mature results of the Spanish Lung Cancer Group 0008 study. Lung Cancer. 2013 Jul;81(1):84-90. doi: 10.1016/j.lungcan.2013.03.009. Epub 2013 Apr 21.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Weight loss \< 5 % within the last 3 months
At least one measurable lesion
Planning CT scan previous to randomization
Written informed consent
You may not qualify if:
Malignant effusion, supraclavicular node or SVCS
PTV \> 2000 cm3
V20 \> 35%
FEV1 and DLCO both \< 30% or 1 liter at study entry
Contact the study team to confirm eligibility.
Cycloparaffins
Hydrocarbons, Alicyclic
Hydrocarbons, Cyclic
Hydrocarbons
Organic Chemicals
Diterpenes
Terpenes
Primary Completion
July 2006
Actual (reported)
Study Completion
December 2007
Actual (reported)
Last Updated
May 23, 2025
Record last verified: 2025-05
Data Sharing
IPD Sharing
Will not share
Source record
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Source: ClinicalTrials.gov.
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