Status:
COMPLETED
Tarceva And Radiotherapy in Locally Advanced Lung Cancer Non-small Cell Lung Cancer
Lead Sponsor:
Olfred Hansen
Collaborating Sponsors:
Odense University Hospital
Copenhagen University Hospital at Herlev
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
The trial is a phase II study of daily Tarceva combined with definitive radiotherapy in inoperable locally advanced non small cell lung cancer (stage IIB-IIIB). The objective of the phase II trial is ...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Patients with histologically or cytologically documented diagnosis locally advanced NSCLC stage IIB to IIIB without pleural effusion
- Performance status ≤2 on the ECOG scale
- Serum bilirubin must be ≤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 malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer)
- Inability to take oral medication, or requirement of intravenous alimentation
- Nursing mothers
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00888511
Start Date
May 1 2009
End Date
May 1 2016
Last Update
November 27 2020
Active Locations (7)
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1
Department of Oncology, Aarhus University Hospital
Aarhus, Denmark, 8000
2
Department of Oncology, Rigshospitalet
Copenhagen, Denmark, 2100
3
Department of Oncology, Copenhagen University Hospital at Herlev
Herlev, Denmark, 270
4
Department of Oncology, Naestved Hospital
Næstved, Denmark