Status:
COMPLETED
Oral Chemotherapy And Platinum With Radiotherapy Followed Or Not By Consolidation With The Same Chemotherapy In Locally Advanced Non Small Cell Lung Cancer
Lead Sponsor:
Pierre Fabre Medicament
Collaborating Sponsors:
Pierre Fabre Pharma GmbH
Conditions:
NSCLC
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This is a multicenter, open-label, randomised, phase III study of 2 cycles of oral vinorelbine in combination with cisplatin concurrently with radiotherapy randomised to either two more cycles of cons...
Eligibility Criteria
Inclusion
- Main
- Presence of at least one measurable lesion (RECIST criteria)
- Patients with a Karnofsky Performance Status = or \> 80%
- Adequate pulmonary function, bone marrow, hepatic and renal functions
- Main
Exclusion
- Patients with NSCLC stage IV, with NSCLC stages I, II, IIIA (except N2), with NSCLC stage IIIB with tumour extent or pleural effusion
- Symptomatic neuropathy \> Grade 1
- Hearing impairment = or \> Grade 2
- Concomitant/uncontrolled medical disorder
- Pregnant women
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT00683514
Start Date
April 1 2005
Last Update
October 4 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Pierre Fabre Pharma GmbH
Freiburg im Breisgau, Jechtinger Str. 13, Germany, D-79111