Non-Small Cell Lung Cancer Clinical Trial
Official title:
Cisplatin/Etoposide Followed by Twice-Daily Chemoradiation (hfRT/CT) Versus Cisplatin/Etoposide Alone Before Surgery in Stage III Non-Small Cell Lung Cancer. A Phase III Trial of the German Lung Cancer Cooperative Group (GLCCG)
Patients are randomized to (arm A) 3 cycles of cisplatin/etoposide, followed by
hyperfractionated radiotherapy (hfRT)with concurrent carboplatin and vindesine then surgery
and, if no or R1/2-resection, additional hfRT versus (arm B) 3 cycles of
cisplatin/etoposide, followed by surgery and then RT.
The primary endpoint was progression free survival (PFS). With 500 patients evaluable an
improvement of median PFS from 10 to 14 months could be detected.
Status | Completed |
Enrollment | 500 |
Est. completion date | September 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 69 Years |
Eligibility |
Inclusion Criteria: - non-small cell lung cancer proven by histology - stage IIIA / stage IIIB - mediastinoscopy - performance score ECOG 0,1 - predicted postoperative FEV 1 > 1.0 l Exclusion Criteria: - small cell lung cancer - cardiac disability (NYHA III/IV) - prior radio- or chemotherapy - pregnancy - other malignancy |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Heidelberg University | FLT Berlin / Buch, Kreiskrankenhaus Diekholzen, Lung Clinic Hemer, University Hospital Muenster, University Hospital, Saarland |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression free survival | |||
Secondary | Overall survival |
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