Tarceva And Radiotherapy in Locally Advanced Lung Cancer Non-small Cell Lung Cancer

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Olfred Hansen
• Collaborators: Aalborg Universitetshospital; Aalborg University Hospital; Aarhus University Hospital; Copenhagen University Hospital at Herlev; Naestved Hospital; Odense University Hospital; Rigshospitalet, Denmark
• Treatments: Erlotinib Hydrochloride

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