Status:
COMPLETED
Navelbine And Radiotherapy in Locally Advanced Lung Cancer
Lead Sponsor:
Odense University Hospital
Collaborating Sponsors:
Aarhus University Hospital
Vejle Hospital
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief Summary
This study is an open label randomized multi-centre phase II trial in patients with inoperable locally advanced stage IIB-IIIB Non Small Cell Lung Cancer who fulfils the general criteria for curativel...
Detailed Description
This study was an open label randomized multi-centre phase II trial in patients with inoperable locally advanced stage IIB-IIIB Non Small Cell Lung Cancer who fulfils the general criteria for curative...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Patients with histologically or cytologically documented diagnosis of locally advanced NSCLC stage IIB to IIIB without pleural effusion
- Performance status 0-1 on the ECOG scale
- Weight loss ≤10% during the last 6 months
- Adequate lung function measured as FEV1 ≥1.0
- Neutrophile count ≥1.5 x 109/L and platelet count ≥100 x 109/L
- Serum bilirubin ≤1.5 upper limit of normal (ULN)
- ALAT ≤2 x ULN
- Able to comply with study and follow-up procedures
- Patients with reproductive potential must use effective contraception
- Written (signed) informed consent to participate in the study
Exclusion
- Any unstable systemic disease (including active infection, unstable angina, congestive heart failure, severe hepatic, renal, or metabolic disease)
- Any other active malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer)
- Prior chemotherapy for lung cancer, including neo- and adjuvant chemotherapy
- Inability to take oral medication, or requirement of intravenous alimentation
- Active peptic ulcer disease
- Nursing mothers
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT00887783
Start Date
May 1 2009
End Date
September 1 2016
Last Update
May 17 2022
Active Locations (6)
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1
Department of Oncology, Aalborg University Hospital
Aalborg, Denmark, 9100
2
Department of Oncology, Aarhus University Hospital
Aarhus, Denmark, 8000
3
Department of Oncology, Copenhagen University Hospital Herlev
Herlev, Denmark, 2730
4
Department of Oncology, Odense University Hospital
Odense, Denmark, 5000