Individualized Treatment Based on Epidermal Growth Factor Receptor Mutations and Level of BRCA1 E… (NCT00883480) | Clinical Trial Compass
CompletedNot Applicable
Individualized Treatment Based on Epidermal Growth Factor Receptor Mutations and Level of BRCA1 Expression in Advanced Adenocarcinoma
Spain153 participantsStarted 2005-06
Plain-language summary
This is a pharmacogenic, prospective, and multicenter study in patients with advanced lung adenocarcinoma.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients age 18 years or more.
* Histologically confirmed diagnosis of non-small-cell lung carcinoma.(and indifferentiated and BAC histology).
* Only patients with advanced disease, defined as stage IV or IIIB with/without pleural effusion, will be included.
* Tumor sample available.
* A measurable lesion, as defined by RECIST criteria.
* Karnofsky score 60% or more (ECOG \< 2).
* Patients should not have received previous treatment with chemotherapy or other agents for disseminated disease. Chemotherapy is allowed if the initial diagnosis of the patient is limited disease and the patient has received adjuvant or neoadjuvant treatment.
* Patients with cerebral disease are permitted, without any time limitations after holocranial irradiation or complementary antiedema treatment.
* Patients with hepatical, renal and hematology normality values.
* Patients should sign an informed consent form before inclusion in the study that specifies that the clinical trial treatment entails consent for the analysis of biological samples of tumor and blood.
* Patients of childbearing age of either sex must use effective contraceptive methods (barrier methods or other birth control methods) before entering the study and while participating in the study.
* Patients must be available for clinical follow-up..
Exclusion Criteria:
* Patients who have received an investigational medicinal product in the 21 days before inclusion in the study or antiEGFR receptor ag…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Tumoral Response (RECIST criteria)
Timeframe: From date of end of experimental treatment until the date of last follow up, assessed up to 24 months]