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This is a pharmacogenic, prospective, and multicenter study in patients with advanced lung adenocarcinoma.
Pharmacogenomic study, prospective, multicenter. Individualized treatment based on EGFR mutations and level of BRCA1 expression in patients with advanced lung adenocarcinoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Experimental | The rest of the patients who do not carry the Factor Receptor mutation of Epidermal Growth will receive chemotherapy treatment individualized based on BRCA 1 m RNA levels. Function of these levels, three different subgroups of treatment: Subgroup A with low BRCA1 mRNA levels will receive treatment with gemcitabine / cisplatin Subgroup B with intermediate levels of BRCA1 mRNA: will receive treatment with docetaxel / cisplatin Subgroup C with high levels of BRCA1 mRNA: will receive treatment with docetaxel |
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| 1 | Experimental | The group of patients carrying EGFR mutation will receive treatment with Erlotinib, a selective oral Receptor tyrosine kinase inhibitor Epidermal Growth Factor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | Docetaxel 75 mg/day 1 x 4 cycles |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Tumoral Response (RECIST criteria) | To evaluate the tumor response of the treatment as measured by investigator-assessed overall response rate according to RECIST v1.1. | From date of end of experimental treatment until the date of last follow up, assessed up to 24 months] |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Time from randomization until death from any cause. Patients who have not died during the study will be tabulated on their last date of evaluation. | From the date of randomization to the date of last follow up or death, assessed up to 24 months |
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Inclusion Criteria:
Patients age 18 years or more.
Histologically confirmed diagnosis of non-small-cell lung carcinoma.(and indifferentiated and BAC histology).
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:
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| Name | Affiliation | Role |
|---|---|---|
| Rafael Rosell, MD | ICO-HOSPITAL GERMANS TRIAS I PUJOL | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ico-Hospital Universitarios Germans Trias I Pujol | Badalona | Barcelona | 08916 | Spain | ||
| Hospital Carlos Haya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19415121 | Derived | Rosell R, Perez-Roca L, Sanchez JJ, Cobo M, Moran T, Chaib I, Provencio M, Domine M, Sala MA, Jimenez U, Diz P, Barneto I, Macias JA, de Las Penas R, Catot S, Isla D, Sanchez JM, Ibeas R, Lopez-Vivanco G, Oramas J, Mendez P, Reguart N, Blanco R, Taron M. Customized treatment in non-small-cell lung cancer based on EGFR mutations and BRCA1 mRNA expression. PLoS One. 2009;4(5):e5133. doi: 10.1371/journal.pone.0005133. Epub 2009 May 5. |
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| Cisplatin | Drug | Docetaxel-Cisplatin 75 mg/day 1 x 4 cycles |
|
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| Gemcitabine | Drug | Cisplatin 75 mg/ day 1 x 4 cycles Gemcitabine 1250 mg/ day 1 and 8 x 4 cycles |
|
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| Erlotinib | Drug | Erlotinib 150 mg/day x 21 days |
|
|
| Málaga |
| Málaga |
| Spain |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D002945 | Cisplatin |
| D000093542 | Gemcitabine |
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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