Non-small Cell Lung Cancer
Conditions
Keywords
Lung cancer, Non-small cell lung cancer, Tarceva, Radiotherapy, Local-regionally advanced non-small cell lung cancer
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 to examine Tarceva concomitant with curatively intended irradiation 66 Gy (2 Gy x 33 F, 5 F per week).
Interventions
DRUGTarceva
Tarceva 150 mg/day
RADIATIONRadiotherapy
66 Gy/33 F/5 F per week for 5 weeks
Sponsors
Odense University Hospital
Copenhagen University Hospital at Herlev
Rigshospitalet, Denmark
Aalborg University Hospital
Aarhus University Hospital
Naestved Hospital
Olfred Hansen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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 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 | Description |
|---|---|---|
| Progression Free Survival | 3 years | Progression free survival from registration according to RECIST 1.1 |
Secondary
| Measure | Time frame |
|---|---|
| Local Tumor Control by CT-scan | May 2012 |
| Overall Response Rate (CR + PR) | May 2012 |
| Local Tumor Control at 9 Months Evaluated by PET-CT | May 2012 |
| Toxicity | 3 years |
| Disease Free Survival | May 2012 |
| Late Toxicity | May 2012 |
| Overall Survival | May 2012 |
Countries
Denmark
Participant flow
Recruitment details
July 2007 - November 2013
Participants by arm
| Arm | Count |
|---|---|
| Concurrent Tarceva and RT in LA-NSCLC Tarceva: Tarceva 150 mg/day
Radiotherapy: 66 Gy/33 F/5 F per week for 5 weeks | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Concurrent Tarceva and RT in LA-NSCLC |
|---|---|
| Age, Continuous | 75 years |
| Region of Enrollment Denmark | 15 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 15 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 3 / 15 |
Outcome results
Primary
Progression Free Survival
Progression free survival from registration according to RECIST 1.1
Time frame: 3 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Concurrent Tarceva and RT in LA-NSCLC | Progression Free Survival | 9.4 months |
Secondary
Disease Free Survival
Time frame: May 2012
Secondary
Late Toxicity
Time frame: May 2012
Secondary
Local Tumor Control at 9 Months Evaluated by PET-CT
Time frame: May 2012
Secondary
Local Tumor Control by CT-scan
Time frame: May 2012
Secondary
Overall Response Rate (CR + PR)
Time frame: May 2012
Secondary
Overall Survival
Time frame: May 2012
Secondary
Toxicity
Time frame: 3 years