Thoracal Radiotherapy and Tarceva

• Status: Terminated
• Trial end date: 2020-12-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if erlotinib given orally along with concurrent palliative irradiation to lung cancer improves local control compared to those treated with radiotherapy alone.

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

Details

• Lead Sponsor: Oslo University Hospital
• Treatments: Erlotinib Hydrochloride

Criteria

Inclusion Criteria:

• Age >18 years

• Histological or cytological verified NSCLC

• Palliative radiotherapy to thorax indicated

• ECOG Performance status 0-2

• Fertile patients must use contraception

• Signed informed consent

• Ability to understand and fill in QoL questionnaires

• Capability to take per os medication

• Serum bilirubin < 2 times upper limit of normal (ULN)

• AST and ALT < 2 times ULN (< 5 times ULN if liver metastases are present)

• Creatinine < 5 times ULN

Exclusion Criteria:

• Pregnancy or nursing

• Other prior or concurrent malignant disease likely to interfere with study treatment or comparisons

• No evidence of other significant laboratory finding or concurrent uncontrolled medical illness, that in the opinion of the investigator, would interfere with study treatment or results comparison or render the patient at high risk for treatment complications

• No prior radiotherapy to the same organ / place

• No concurrent treatment with other experimental drugs

• Known brain metastases in need of radiotherapy

• Known hypersensitivity to erlotinib or other substances in the erlotinib tablets.