A Multicenter Phase II Study of Carboplatin Plus Gemcitabine Followed by Concomitant Chemoradiation in Patients With Non-Resectable Stage III Non-Small-Cell-Lung Cancer
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Non-Small-Cell-Lung Cancer
Both
Non-Small-Cell-Lung Cancer
Trial Information
A Multicenter Phase II Study of Carboplatin Plus Gemcitabine Followed by Concomitant Chemoradiation in Patients With Non-Resectable Stage III Non-Small-Cell-Lung Cancer
Inclusion Criteria:
- cytological or histologically proven NSCLC
- unresectable stage III NSCLC
- presence of at least one measurable lesion (RECIST criteria)
- adequate haematological, renal and hepatic function
- adequate lung function reserve
- good condition, weight loss <10% over previous 6 months, life expectancy > 3 months
Exclusion Criteria:
- previous chemotherapy for NSCLC
- distant metastasis or a pleural or pericardial effusion
- treatment for malignant disease in the past or serious concomitant medical or
psychiatric disease
- active uncontrolled infection at time of inclusion
- interstitial lung disease
- auto-immune systemic disease with potential involvement of the lungs
- concomitant use of amiodarone
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
2-year survival rates
Principal Investigator
Paul R Germonpre
Investigator Role:
Principal Investigator
Investigator Affiliation:
Thoracic Oncology Group Antwerp
Authority:
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Study ID:
CHER@NOS
NCT ID:
NCT00463515
Start Date:
January 2003
Completion Date:
April 2008
Related Keywords:
- Non-Small-Cell-Lung Cancer
- Non-Small Cell Lung Cancer
- NSCLC
- Chemoradiation
- lung cancer
- induction chemotherapy
- chemo-radiotherapy
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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