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Trial Title:
Study of 3D Radiotherapy With or Without Erlotinib (Tarceva®) in Patients With Localized Non-Small Cell Lung Cancer
NCT ID:
NCT00466089
Condition:
Carcinoma, Non-Small-Cell Lung
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Erlotinib Hydrochloride
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
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Erlotinib (Tarceva®)
Description:
Erlotinib (Tarceva®), 150mg/day p.o during 6 months.
Arm group label:
1
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:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital de Navarra
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Enrique Martinez, Dr.
Email:
Principal Investigator
Facility:
Name:
Hospital Clínic i Provincial de Barcelona
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Nuria Viñolas, Dr.
Email:
Principal Investigator
Investigator:
Last name:
Francesc Casas, Dr.
Email:
Principal Investigator
Facility:
Name:
Hospital Puerta de Hierro
Address:
City:
Madrid
Zip:
28035
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Alejandro De la Torre, Dr.
Email:
Principal Investigator
Facility:
Name:
Fundación Jimenez Diaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Ana Mª Perez Casas, Dr.
Email:
Principal Investigator
Facility:
Name:
Hospital de Donostia
Address:
City:
San Sebastian
Zip:
20080
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Julian Minguez, Dr.
Email:
Principal Investigator
Start date:
March 2006
Lead sponsor:
Agency:
Hospital of Navarra
Agency class:
Other
Collaborator:
Agency:
Dr. Enrique Martínez López
Agency class:
Other
Source:
Hospital of Navarra
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00466089
