Radical Treatment of Synchronous Oligometastatic Non-Small Cell Lung Carcinoma
Carcinoma, Non-Small-Cell Lung, Synchronous Neoplasms
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring oligometastatic disease, radical treatment
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Instituto Nacional de Cancerologia
Arms of the Study
Arm 1
Experimental
single arm
Patients with synchronous metastases at Central Nervous System (CNS), evaluated in less than one week by the Multidisciplinary Committee at National Cancer Institute of Mexico to define the initial treatment. Patients with metastases at other sites than CNS will receive first line systemic treatment, in those EGFR-mutated with tyrosine kinase inhibitors (TKI) and in patients without a driver mutation with first line duplet of chemotherapy based on platin. The type of TKI or chemotherapy will be at discretion of the treating physician. After 4 cycles of treatment, patients with stable disease or partial response will be evaluated by de Multidisciplinary Committee to establish the type of radical treatment to the primary and to the metastases, radiation therapy and chemoradiotherapy.