Trial Information
Randomized Phase II Trial Using Concomitant Chemoradiation Plus Induction or Consolidation Chemotherapy for Unresectable Stage III Non-small Cell Lung Cancer Patients
Inclusion Criteria:
- Unresectable stage IIIA or B NSCLC patients
- WHO PS 0 or 1
- Weight loss < 5 % within the last 3 months
- At least one measurable lesion
- Planning CT scan previous to randomization
- Written informed consent
Exclusion Criteria:
- Malignant effusion, supraclavicular node or SVCS
- PTV > 2000 cm3
- V20 > 35%
- FEV1 and DLCO both < 30% or 1 liter at study entry
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:
Overall response rate
Safety Issue:
No
Principal Investigator
Pilar Garrido, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hospital Ramon y Cajal (Madrid)
Authority:
Spain: Spanish Agency of Medicines
Study ID:
GECP 00-08 / TAX.ES1.209
NCT ID:
NCT01652820
Start Date:
October 2001
Completion Date:
December 2007
Related Keywords:
- Non Small-cell Lung Cancer
- LUNG
- DOCETAXEL
- GEMCITABINE
- CARBOPLATIN
- RADIOTHERAPY
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms