Status:
UNKNOWN
Study of 3D Radiotherapy With or Without Erlotinib (Tarceva®) in Patients With Localized Non-Small Cell Lung Cancer
Lead Sponsor:
Hospital of Navarra
Collaborating Sponsors:
Dr. Enrique Martínez López
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 susceptibl...
Eligibility Criteria
Inclusion
- 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
- 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:
- Unstable cardiopathy despite treatment, myocardial infarction within the 6 months before entering the study
- Uncontrolled active infection
- Uncontrolled peptic ulcer, unstable diabetes mellitus or any other contraindication for treatment with corticosteroids.
- 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.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00466089
Start Date
March 1 2006
Last Update
January 10 2008
Active Locations (5)
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1
Hospital Clínic i Provincial de Barcelona
Barcelona, Barcelona, Spain, 08036
2
Hospital Puerta de Hierro
Madrid, Madrid, Spain, 28035
3
Fundación Jimenez Diaz
Madrid, Madrid, Spain, 28040
4
Hospital de Navarra
Pamplona, Navarre, Spain, 31008