Clinical trial NCT00888511: Tarceva And Radiotherapy in Locally Advanced Lung Cancer Non-small Cell Lung Cancer
Official title: Concomitant Tarceva® and Irradiation in Patients in Local-regionally Advanced Non-small Cell Lung Cancer. A Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: Lung cancer
Non-small cell lung cancer
Tarceva
Radiotherapy
Local-regionally advanced non-small cell lung cancer
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
name: Copenhagen University Hospital at Herlev
name: Rigshospitalet, Denmark
name: Aalborg University Hospital
name: Aarhus University Hospital
name: Naestved Hospital
First posted: 2009-04-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Progression Free Survival
timeFrame: 3 years
Secondary outcomes:
measure: Toxicity
timeFrame: 3 years
measure: Local Tumor Control by CT-scan
timeFrame: May 2012
measure: Overall Response Rate (CR + PR)
timeFrame: May 2012
measure: Local Tumor Control at 9 Months Evaluated by PET-CT
timeFrame: May 2012
measure: Overall Survival
timeFrame: May 2012
measure: Disease Free Survival
timeFrame: May 2012
measure: Late Toxicity
timeFrame: May 2012
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Oncology, Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Department of Oncology, Rigshospitalet
city: Herlev
country: Denmark
facility: Department of Oncology, Copenhagen University Hospital at Herlev
city: Naestved
country: Denmark
facility: Department of Oncology, Naestved Hospital
city: Odense
country: Denmark
facility: Laboratory of Radiation Physics
city: Odense
country: Denmark
facility: Odense University Hospital
city: Vejle
country: Denmark
facility: Department of Oncology, Vejle Hospital
Study officials:
affiliation: Odense University Hospital
name: Olfred Hansen, MD
role: PRINCIPAL_INVESTIGATOR
References: