Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
NSCLC, lung cancer, Patients with localized-unresectable (IA-IIIB) non-small cell lung cancer non susceptible for chemotherapy treatment.
Brief summary
A phase II, multicenter, randomized trial of 3D Radiotherapy versus 3D Radiotherapy and erlotinib (Tarceva®) in patients with localized-unresectable (IA-IIIB) non-small cell lung cancer non susceptible for chemotherapy treatment, to compare safety and toxicity profile, and the progression-free survival in both arms of treatment (3D Radiotherapy versus 3D Radiotherapy + erlotinib) in patients who have not received previous chemotherapy.
Interventions
Erlotinib (Tarceva®), 150mg/day p.o during 6 months.
Sponsors
Dr. Enrique Martínez López
Hospital of Navarra
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 correct follow-up. * 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 measures.
Exclusion criteria
* 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 the study. * Prior treatment with EGFR targeted therapies. * Erlotinib known hypersensibility. * Any radiotherapy treatment contraindication. * History of significant neurological or psychiatric disorders, including epileptic seizures. * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determinate the viability and toxicity profile of Erlotinib + 3D Radiotherapy treatment (% of patients presenting toxicity 3-4 during the treatment). | — |
Secondary
| Measure | Time frame |
|---|---|
| The progression-free survival. | — |
| 1-year survival. | — |
| Overall survival. | — |
| Objective response rate, according to RECIST criteria. | — |
Countries
Spain
Contacts
Primary ContactEnrique Martinez, Dr.
Outcome results
None listed