Tratamiento Individualizado en función de Las Mutaciones en EGFR y Del Nivel de expresión de BRCA1 en Pacientes Con Adenocarcinoma de pulmón Avanzado
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 试验地点
- 3
- 主要终点
- Tumoral Response (RECIST criteria)
研究概览
简要总结
This is a pharmacogenic, prospective, and multicenter study in patients with advanced lung adenocarcinoma.
详细描述
Pharmacogenomic study, prospective, multicenter. Individualized treatment based on EGFR mutations and level of BRCA1 expression in patients with advanced lung adenocarcinoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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..
排除标准
- •Patients who have received an investigational medicinal product in the 21 days before inclusion in the study or antiEGFR receptor agent.
- •Severe comorbidity.
研究组 & 干预措施
2
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
干预措施: Gemcitabine (Drug)
1
The group of patients carrying EGFR mutation will receive treatment with Erlotinib, a selective oral Receptor tyrosine kinase inhibitor Epidermal Growth Factor
干预措施: Erlotinib (Drug)
2
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
干预措施: Docetaxel (Drug)
2
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
干预措施: Cisplatin (Drug)
结局指标
主要结局
Tumoral Response (RECIST criteria)
时间窗: From date of end of experimental treatment until the date of last follow up, assessed up to 24 months]
To evaluate the tumor response of the treatment as measured by investigator-assessed overall response rate according to RECIST v1.1.
次要结局
- Overall Survival(From the date of randomization to the date of last follow up or death, assessed up to 24 months)