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

Olfred Hansen

Status and phase: Completed; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Radiation: Radiotherapy; Drug: Tarceva

Study type: Interventional

Funder types: Other

Identifiers

NCT00888511

09.02

Details and patient eligibility

About

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).

Enrollment: 15 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

1

Experimental group

Treatment:

Radiation: Radiotherapy

Drug: Tarceva