Clinical trial · Interventional
Chemotherapy With or Without Radiosurgery for Asymptomatic Oligo Brain Metastasis
Randomized Phase III Trial of Stereotactic Radiosurgery (SRS) Versus Observation for Patients With Asymptomatic Cerebral Oligo-metastases in Non-small Cell Lung Cancer (NSCLC)
NCT01301560CI-TRIAL-00004451unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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 need of radiosurgery is controversial for asymptomatic oligo brain metastasis for non small cell lung cancer (NSCLC). Therefore, the investigators do a randomized study comparing overall survival between two groups with or without radiosurgery for asymptomatic oligo brain metastasis before palliative chemotherapy for NSCLC.
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 |
|---|---|---|---|
| Nonsmall Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observation | Radiation | — | UNRESOLVED |
| Radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Radiosurgery arm
- description
- Radiosurgery before palliative chemotherapy
- interventionNames
- Radiation: Radiosurgery
- type
- NO_INTERVENTION
- label
- Observation arm
- description
- No radiotherapy or local treatment until specific symptoms or sign developed
- interventionNames
- Radiation: Observation
Primary outcomes (1)
- measure
- overall survival
- timeFrame
- 1 year after the enrollment of the last patient
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed non-small cell lung cancer with synchronous brain metastases 2. One to 4 intraparenchymal brain metastases by contrast-enhanced MRI, meeting the following criteria: * Well circumscribed tumor(s) with brain edema Grade 0-1 * Maximum diameter ≤ 3.0 cm 3. No prior surgical treatment or RT for brain metastases 4. No leptomeningeal metastases by MRI or cerebrospinal fluid evaluation 5. 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: 1. severe co-morbid illness and/or active infections 2. pregnant or lactating women 3. RTOG neurologic function status of 1\~4 4. Uncontrollable extracranial metastases
References
Publications (1)
- DERIVEDLim SH, Lee JY, Lee MY, Kim HS, Lee J, Sun JM, Ahn JS, Um SW, Kim H, Kim BS, Kim ST, Na DL, Sun JY, Jung SH, Park K, Kwon OJ, Lee JI, Ahn MJ. A randomized phase III trial of stereotactic radiosurgery (SRS) versus observation for patients with asymptomatic cerebral oligo-metastases in non-small-cell lung cancer. Ann Oncol. 2015 Apr;26(4):762-768. doi: 10.1093/annonc/mdu584. Epub 2014 Dec 23. PMID 25538174