Vinorelbine/Gemcitabine Verses Vinorelbine/Carboplatin in Advanced Non-Small Cell Lung Cancer
Information source: The Norwegian Lung Cancer Study Group
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Advanced Non-Small Cell Lung Cancer
Intervention: Vinorelbine (Drug); Gemcitabine (Drug); Vinorelbine (Drug); Carboplatin (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: The Norwegian Lung Cancer Study Group Official(s) and/or principal investigator(s):
Øystein Fløtten, Study Chair, Affiliation: Haukeland University Hospital, thoracic department
Overall contact:
Øystein Fløtten, MD, Phone: 55973245, Ext: +47, Email: oystein.flotten@helse-bergen.no
Summary
The purpose of this study is to explore if the combination of vinorelbine and gemcitabine is
better than vinorelbine and carboplatin in the treatment of advanced non-small cell lung
cancer, in terms of survival, quality of life and need for palliative radiotherapy.
Clinical Details
Official title: Vinorelbine Plus Gemcitabine (VG) Versus Vinorelbine Plus Carboplatin (VC) in Advanced Non-Small Cell Lung Cancer. An Open Randomized Multicenter Phase III Trial From Norwegian Lung Cancer Study Group (NLCG)
Study design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: survival
Secondary outcome: Health related quality of life (HrQoL)Toxicity Need for palliative radiotherapy
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Non-small cell lung cancer stage IIIB or IV
- Not eligible for radical radiotherapy or surgery
- WHO performance status 0-2
Exclusion Criteria:
- Pregnancy
- Other clinical active cancer disease
- ALAT/ALP more than 3 times upper normal limit, bilirubin >1. 5 upper limit
- Bowel disease that causes malabsorption
Locations and Contacts
Øystein Fløtten, MD, Phone: 55973245, Ext: +47, Email: oystein.flotten@helse-bergen.no
Øystein Fløtten, Bergen 5000, Norway; Recruiting
Sverre Fluge, Haugesund 7000, Norway; Recruiting
Heidi Rolke, Kristiansand, Norway; Recruiting
Tore Amundsen, Trondheim 7000, Norway; Recruiting
Additional Information
Starting date: September 2007
Last updated: August 19, 2008
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