Clinical trial · Interventional
Radical Treatment of Synchronous Oligometastatic Non-Small Cell Lung Carcinoma
Radical Treatment of Synchronous Oligometastatic Disease and Primary Tumor in Advanced Non-small Cell Lung Carcinoma (NSCLC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Synchronous Neoplasms | Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemoradiotherapy | Other | — | UNRESOLVED |
| First line systemic treatment | Other | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
| Radical treatment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- single arm
- description
- 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.
- interventionNames
- Other: First line systemic treatment
- Other: Radical treatment
- Radiation: radiation therapy
- Other: Chemoradiotherapy
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- From date of diagnosis until the date of death from any cause, assessed up to 100 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (5)
- BACKGROUNDGriffioen GH, Toguri D, Dahele M, Warner A, de Haan PF, Rodrigues GB, Slotman BJ, Yaremko BP, Senan S, Palma DA. Radical treatment of synchronous oligometastatic non-small cell lung carcinoma (NSCLC): patient outcomes and prognostic factors. Lung Cancer. 2013 Oct;82(1):95-102. doi: 10.1016/j.lungcan.2013.07.023. Epub 2013 Aug 6. PMID 23973202
- BACKGROUNDDe Ruysscher D, Wanders R, van Baardwijk A, Dingemans AM, Reymen B, Houben R, Bootsma G, Pitz C, van Eijsden L, Geraedts W, Baumert BG, Lambin P. Radical treatment of non-small-cell lung cancer patients with synchronous oligometastases: long-term results of a prospective phase II trial (Nct01282450). J Thorac Oncol. 2012 Oct;7(10):1547-55. doi: 10.1097/JTO.0b013e318262caf6. PMID 22982655
- BACKGROUNDCollen C, Christian N, Schallier D, Meysman M, Duchateau M, Storme G, De Ridder M. Phase II study of stereotactic body radiotherapy to primary tumor and metastatic locations in oligometastatic nonsmall-cell lung cancer patients. Ann Oncol. 2014 Oct;25(10):1954-1959. doi: 10.1093/annonc/mdu370. Epub 2014 Aug 11. PMID 25114022
- BACKGROUNDAshworth A, Rodrigues G, Boldt G, Palma D. Is there an oligometastatic state in non-small cell lung cancer? A systematic review of the literature. Lung Cancer. 2013 Nov;82(2):197-203. doi: 10.1016/j.lungcan.2013.07.026. Epub 2013 Aug 20. PMID 24051084
- DERIVEDArrieta O, Barron F, Maldonado F, Cabrera L, Corona-Cruz JF, Blake M, Ramirez-Tirado LA, Zatarain-Barron ZL, Cardona AF, Garcia O, Aren O, De la Garza J. Radical consolidative treatment provides a clinical benefit and long-term survival in patients with synchronous oligometastatic non-small cell lung cancer: A phase II study. Lung Cancer. 2019 Apr;130:67-75. doi: 10.1016/j.lungcan.2019.02.006. Epub 2019 Feb 7. PMID 30885354