Asymptomatic Brain Metastasis in Non-small Cell Lung Cancer (NSCLC)

Non-small Cell Lung Cancer Clinical Trial

Official title:

Randomized Phase III Trial of Stereotactic Radiosurgery (SRS) Versus Observation for Patients With Asymptomatic Cerebral Oligo-metastases in Non-small Cell Lung Cancer (NSCLC)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01130766
• Other study ID #: 2009-01-059
• 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. 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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

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