Local-regionally advanced non-small cell lung cancer MedDRA version: 14.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The study population is patients with NSCLC stage IIB - IIIB without pleural effusion suitable for curatively intended irradiation and concomitant Tarceva. - 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the phase II trial is to examine Tarceva concomitant with curatively intended irradiation 66 Gy (2 Gy x 33 F, 5 F per week) Primary endpoint - Local failure free survival at 9 months after start of radiotherapy evaluated at CT scan ;Secondary Objective: Secondary endpoints - Toxicity - Local tumor control by CT-scan - Overall response rate (CR + PR). - Local tumor control at 9 months evaluated by PET-CT - Overall survival - Disease free survival - Late toxicity ;Primary end point(s): 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 to examine Tarceva concomitant with curatively intended irradiation 66 Gy (2 Gy x 33 F, 5 F per week): Primary endpoint - Local failure free survival at 9 months after start of radiotherapy evaluated at CT scan Secondary endpoints Toxicity, Local tumor control by CT-scan, Overall response rate (CR + PR), Local tumor control at 9 months evaluated by PET-CT, Overall survival, Disease free survival, Late toxicity | — |
Countries
Denmark
Outcome results
None listed