Phase II Randomized Trial of 3D Radiotherapy Versus the Combination of 3D Radiotherapy and Erlotinib (Tarceva®) in Patients With Localized-Unresectable Non-Small Cell Lung Cancer Non Susceptible for Chemotherapy Treatment.
- Written informed consent prior to any specific procedure of the protocol.
- Histologically confirmed diagnosis of non small cell lung cancer.
- Unresectable (IA-IIIB) non-small cell lung cancer.
- Patients non susceptible for chemotherapy treatment
- Measurable disease according to RECIST criteria
- Age > 18 years.
- ECOG performance status < 2.
- Adequate bone marrow, hepatic, renal and respiratory function.
- Patients capable of following an adequate therapeutic compliance and accessible for a
- Women at a fertile age must have a negative serum or urine pregnancy test within the
7 days prior to the beginning of the treatment.
- Patients of both genders at a fertile age, including those women having their last
menstruation within the two previous years, must follow effective contraceptive
- Prior chemotherapy or radiotherapy.
- History of other curatively treated malignancy and no evidence of disease within the
past 5 years except squamous cell skin cancer, or resected cervix carcinoma.
- Pregnant or lactating women.
- Any other severe disease or clinical conditions, as, but not only:
1. Unstable cardiopathy despite treatment, myocardial infarction within the 6
months before entering the study
2. Uncontrolled active infection
3. Uncontrolled peptic ulcer, unstable diabetes mellitus or any other
contraindication for treatment with corticosteroids.
4. Autoimmune diseases.
- Concomitant treatment with any other antineoplastic therapy.
- Prior experimental pharmacological agent within the 3 weeks prior to the inclusion of
- Prior treatment with EGFR targeted therapies.
- Erlotinib known hypersensibility.
- Any radiotherapy treatment contraindication.
- History of significant neurological or psychiatric disorders, including epileptic
- Any significant ophthalmologic impairment of the eye surface (Use of contact lenses
is not recommended)
- Inability to take oral medication and surgical procedures affecting the absorption or
implying intravenous or parenteral feeding.
- Any other underlying severe process affecting the ability to take part in the study.