Study of 3D Radiotherapy With or Without Erlotinib (Tarceva®) in Patients With Localized Non-Small Cell Lung Cancer
NCT ID: NCT00466089
Last Updated: 2008-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
90 participants
INTERVENTIONAL
2006-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Thoracal Radiotherapy and Tarceva
NCT02714530
Stereotactic Ablative Radiotherapy in Locally Advanced Non Small Cell Lung Cancer
NCT05291780
Safety Study of Radiotherapy and Concurrent Erlotinib (Tarceva®) for Brain Metastases From a Non-Small Cell Lung Cancer
NCT00536861
Stereotactic Body Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer That Can Be Removed By Surgery
NCT00551369
Tarceva With Whole Brain Radiation Therapy - Brain Mets From Non-Small Cell Lung Cancer
NCT00871923
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
RT + Tarceva
Erlotinib (Tarceva®)
Erlotinib (Tarceva®), 150mg/day p.o during 6 months.
2
RT
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Erlotinib (Tarceva®)
Erlotinib (Tarceva®), 150mg/day p.o during 6 months.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dr. Enrique Martínez López
UNKNOWN
Hospital of Navarra
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. Enrique Martínez López
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Enrique Martínez, Dr.
Role: PRINCIPAL_INVESTIGATOR
Hospital de Navarra
Ana Mª Perez Casas, Dr.
Role: PRINCIPAL_INVESTIGATOR
Fundación Jimenez Diaz
Alejandro De la Torre, Dr.
Role: PRINCIPAL_INVESTIGATOR
Hospital Puerta de Hierro
Francesc Casas, Dr.
Role: PRINCIPAL_INVESTIGATOR
Hospital Clínic i Provincial de Barcelona
Nuria Viñolas, Dr.
Role: PRINCIPAL_INVESTIGATOR
Hospital Clínic i Provincial de Barcelona
Julian Minguez, Dr.
Role: PRINCIPAL_INVESTIGATOR
Hospital de Donostia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Clínic i Provincial de Barcelona
Barcelona, Barcelona, Spain
Hospital Puerta de Hierro
Madrid, Madrid, Spain
Fundación Jimenez Diaz
Madrid, Madrid, Spain
Hospital de Navarra
Pamplona, Navarre, Spain
Hospital de Donostia
Donostia / San Sebastian, San Sebastian, Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MO19182
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.