Radical Treatment of Synchronous Oligometastatic Non-Small Cell Lung Carcinoma
NCT02805530 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2023-05-06
Summary
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.
Conditions
- Carcinoma, Non-Small-Cell Lung
- Synchronous Neoplasms
Interventions
- OTHER
-
First line systemic treatment
Epidermal growth factor receptor (EGFR)-mutated with tyrosine kinase inhibitors (afatinib, erlotinib or gefitinib). Patients without driver mutation duplet of chemotherapy based on platin taking account histologic subtype (Carboplatin or Cisplatin plus pemetrexed for adenocarcinomas, gemcitabine for epidermoid or paclitaxel for both) at discretion of the treating physician.
- OTHER
-
Radical treatment
to the primary and to the metastases will be with surgery, radiotherapy, chemoradiotherapy, stereotactic radiosurgery or radiofrequency ablation.
- RADIATION
-
radiation therapy
Patients will receive dose and fraction regimen according to the metastatic site.
- OTHER
-
Chemoradiotherapy
Chemoradiotherapy with duplet based on platins (Carboplatin or cisplatin plus pemetrexed or paclitaxel or etoposide or vinorelbine) or monotherapy with carboplatin.
Sponsors & Collaborators
-
Instituto Nacional de Cancerologia de Mexico
lead OTHER
Principal Investigators
-
Oscar Arrieta, MD · Instituto Nacional de Cancerologia de Mexico
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-06-30
- Primary Completion
- 2018-08-31
- Completion
- 2019-01-31
Countries
- Mexico
Study Locations
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