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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT01130766
Other study ID # 2009-01-059
Secondary ID
Status Enrolling by invitation
Phase Phase 3
First received May 25, 2010
Last updated May 25, 2010
Start date June 2008

Study information

Verified date April 2010
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 176
Est. completion date
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 ? No leptomeningeal metastases by MRI or cerebrospinal fluid evaluation

- Patients without any symptoms or signs from brain metastases (RTOG neurologic functions status of 0) ? Age, 18 and over ? ECOG performance status 0-1 ? Written informed consent

Exclusion Criteria:

- severe co-morbid illness and/or active infections ? pregnant or lactating women

- RTOG neurologic function status of 1~4 ? Uncontrollable extracranial metastases

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
stereotactic radiosurgery (SRS)
Stereotactic radiosurgery using ?-rays from radioactive Cobalt-60 installed in Gamma Knife (Elekta Instruments, Stockholm, Sweden)

Locations

Country Name City State
Korea, Republic of Samsung Medical Center Seoul,

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival 36 months No
Secondary time to CNS progression 36 months No
Secondary time to symptomatic brain metastasis 36 months No
Secondary quality of life 36 months No
Secondary cause of death (neurologic vs. others) 36 months No
Secondary neurocognitive function 36 months No
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