Clinical trial · Interventional
Asymptomatic Brain Metastasis in Non-small Cell Lung Cancer (NSCLC)
Randomized Phase III Trial of Stereotactic Radiosurgery (SRS) Versus Observation for Patients With Asymptomatic Cerebral Oligo-metastases in Non-small Cell Lung Cancer (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)
The prognosis of NSCLC patients with asymptomatic brain metastasis, who are not treated with SRS or WBRT has not been fully investigated yet. This randomized phase III trial is conducted to determine the exact role of SRS in NSCLC patients with asymptomatic oligo brain metastases whether early treatment with SRS would improve survival even in patients with asymptomatic brain metastasis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| stereotactic radiosurgery (SRS) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- stereotactic radiosurgery (SRS)
- interventionNames
- Procedure: stereotactic radiosurgery (SRS)
- type
- NO_INTERVENTION
- label
- observation
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- 36 months
Secondary outcomes (5)
- measure
- time to CNS progression
- timeFrame
- 36 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically confirmed non-small cell lung cancer with synchronous brain metastases (diagnosis of brain lesion before or within 2 months from diagnosis of the primary site tumor)
* One to 4 intraparenchymal brain metastases by contrast-enhanced MRI, meeting the following criteria:
1. Well circumscribed tumor(s) with brain edema Grade 0-1
2. Maximum diameter ≤ 3.0 cm
* No prior complete resection of all known brain metastases or RT ④ No leptomeningeal metastases by MRI or cerebrospinal fluid evaluation
* Patients without any symptoms or signs from brain metastases (RTOG neurologic functions status of 0) ⑥ Age, 18 and over ⑦ ECOG performance status 0-1 ⑧ Written informed consent
Exclusion Criteria:
* severe co-morbid illness and/or active infections ② pregnant or lactating women
* RTOG neurologic function status of 1\~4 ④ Uncontrollable extracranial metastasesReferences
Publications (0)
Data not yet available