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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)

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01301560
Enrollment
176
Registered
2011-02-23
Start date
2008-06-30
Completion date
Unknown
Last updated
2011-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonsmall Cell Lung Cancer

Keywords

Asymptomatic brain metastasis, NSCLC, GKS

Brief summary

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.

Interventions

RADIATIONRadiosurgery

Gamma knife surgery for asymptomatic oligo-metastasis to brain from NSCLC

RADIATIONObservation

No local treatment

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
overall survival1 year after the enrollment of the last patient

Secondary

MeasureTime frame
Time to CNS progression1 year after the enrollment of the last patient

Countries

South Korea

Contacts

Primary ContactMyung-Ju Ahn, Pf
silkahn@skku.edu82-2-3410-3459

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026