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Randomized Phase II Trial Using Concomitant Chemoradiation Plus Induction or Consolidation Chemotherapy for Unresectable Stage III Non-small Cell Lung Cancer Patients


Phase 2
18 Years
N/A
Not Enrolling
Both
Non Small-cell Lung Cancer

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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

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