Status:
COMPLETED
Evaluation of Carboplatin Plus Gemcitabine Followed by Concomitant Chemoradiation for Non-resectable Stage III NSCLC
Lead Sponsor:
University Hospital, Antwerp
Collaborating Sponsors:
Universiteit Antwerpen
Eli Lilly and Company
Conditions:
Non-Small-Cell-Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The aim of this study is to evaluate whether by combining a carboplatin-gemcitabine based induction chemotherapy with weekly cisplatin during standard thoracic radiotherapy it is possible to obtain op...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00463515
Start Date
January 1 2003
End Date
November 1 2006
Last Update
July 12 2013
Active Locations (3)
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1
ZNA Middelheim
Antwerp, Antwerp, Belgium
2
University Hospital Antwerp
Edegem, Antwerp, Belgium
3
Sint Augustinus Ziekenhuis
Wilrijk, Antwerp, Belgium