Radical Treatment of Synchronous Oligometastatic Disease and Primary Tumor in Advanced Non-small Cell Lung Carcinoma (NSCLC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
Non-small cell lung cancer (NSCLC) is the most frequent neoplasm worldwide and also represents the main cause of cancer death. However, it represents the main cause of death by cancer. The prognosis of survival at 5 years is poor, approximately 13-15%.
Various studies suggest that patients who clinically present with a limited number of metastases, a term defined as oligometastatic disease, could have a better prognosis of survival with a radical treatment, than for their counterparts with a greater number of metastasis.
The purpose of this study is to add more information to the current medical literature about the benefits in overall survival of radical treatment of oligometastatic disease in patients with NSCLC and equal or less than 5 synchronous metastases at the time of diagnosis.
The outcomes of the study are to determine the global survival and progression-free survival in patients with synchronous oligometastatic (equal to or less than 5 sites) advanced NSCLC undergoing radical treatment of all metastatic sites and the primary tumor.
详细描述
Non-small cell lung cancer (NSCLC) is the most frequent neoplasm worldwide and also represents the main cause of cancer death. However, it represents the main cause of death by cancer. The prognosis of survival at 5 years is poor, approximately 13-15%.
The timely detection of NSCLC is difficult and the options for curative treatment are limited since the majority of patients are diagnosed in advanced stages. The standard treatment in metastatic disease is cytotoxic chemotherapy with platins (cisplatin or carboplatin) in combination with a third generation drug (vinorelbine, paclitaxel, docetaxel, gemcitabine or pemetrexed). This therapeutic scheme results in response rates between 20-30%, with a mean overall survival between 8-11 months.
In recent years, research in oncology has focused on the development of therapies aimed at molecular targets that control the growth and proliferation of the tumor cell. Various monoclonal antibodies (bevacizumab, cetuximab) and tyrosine kinase inhibitors (erlotinib, gefitinib, afatinib, crizotinib) have been evaluated with this purpose in NSCLC treatment. Clinical studies in advanced NSCLC, using these new drugs with or without chemotherapy, have had favorable results by increasing the progression-free survival and the response rate, without being able to demonstrate to date, a significant improvement in the overall survival.
Various studies suggest that patients who clinically present with a limited number of metastases, a term defined as oligometastatic disease, could have a better prognosis of survival with a radical treatment, than for their counterparts with a greater number of metastasis.
Much of the current medical information on clinical outcomes in oligometastatic disease is based on clinical studies and retrospective case series of institutions. The majority of the reports have included a mix of patients with synchronous and metachronous oligometastatic disease, focusing on the radical treatment of specific sites such as the brain and adrenal glands. These results have been recognized by the European Society for Medical Oncology (ESMO) and have been included in its treatment guidelines for lung cancer (2012). The recommendation states to consider some radical treatment in selected patients with solitary metastases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Pathology diagnosis of non-small cell lung cancer
- •Any histology type (adenocarcinoma, epidermoid carcinoma or large cell carcinoma)
- •age ≥18 years.
- •Eastern Cooperative Oncology Group (ECOG) score 0-1
- •Clinical stage IV according to staging system American Joint Committee on Cancer (AJCC) seventh EDITION
- •Oligometastatic disease defined as metastases equal to or less than 5 sites.
- •Synchronous metastases defined as those that are identified within the first month of the diagnosis of the primary tumor.
- •Laboratory results: plasma leukocyte ≥3,000/mm3, platelets ≥100,000/mm3, hemoglobin ≥ 10 gr/dl, serum Creatinine ≤ 1.5 mg/dl, total bilirubin ≤1.5, transaminases ≤ 2.5 times the upper limit of normal (ULN), alkaline phosphatase < 5 times the ULN.
- •Candidate to platinum-based chemotherapy.
- •Life expectancy estimated with treatment of at least 24 weeks.
- •Must have understood and signed the informed consent
排除标准
- •Concurrent uncontrolled diseases
- •Patients with malignant pleural or pericardial effusion.
- •Previous treatments (radiotherapy treatment to the primary site, chemotherapy or treatment with tyrosine kinase inhibitor.)
- •Pregnant or lactating women.
- •Intercurrent malignant diseases, except basal cell carcinoma in skin inactive, carcinoma in situ of the cervix, when completely resected.
结局指标
主要结局
Overall survival
时间窗: From date of diagnosis until the date of death from any cause, assessed up to 100 months
Time to event as calculated from confirmed histopathological diagnosis of NSCLC up until death or last follow up.
次要结局
- Progression-free survival(From date of treatment start until the date of documented radiological (CT) progression, or date of death from any cause, whichever came first, assessed up to 100 months.)
- Complete metabolic response by PET-CT(From date of administration of first-line therapy (any therapy) until the date of metabolic progression as assessed by FDG PET-CT, date of death from any cause, whichever came first, assessed up to 100 months)
研究者
Oscar Gerardo Arrieta Rodríguez
Medical Sciences Researcher (SNI III)
Instituto Nacional de Cancerologia de Mexico