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Study of 3D Radiotherapy With or Without Erlotinib (Tarceva®) in Patients With Localized Non-Small Cell Lung Cancer
Conditions
Carcinoma, Non-Small-Cell Lung
Conditions: official terms
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.
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Erlotinib (Tarceva®)
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
- 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.
Locations
Hospital de Navarra
Pamplona, Navarra, Spain
Hospital Clínic i Provincial de Barcelona
Status: Recruiting
Barcelona, Spain
Fundación Jimenez Diaz
Status: Recruiting
Madrid, Spain
Hospital Puerta de Hierro
Status: Recruiting
Madrid, Spain
Hospital de Donostia
Status: Recruiting
San Sebastian, Spain
Status: Recruiting
Start Date
March 2006
Sponsors
Hospital of Navarra
Source
Hospital of Navarra
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page