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

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01130766
• Collaborator: (none)
• Enrollment: 176
• Location: 1
• Arms: 2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	Procedure: stereotactic radiosurgery (SRS)	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 176 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Study Start Date: Jun 1, 2008
• Anticipated Primary Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: stereotactic radiosurgery (SRS)	Procedure: stereotactic radiosurgery (SRS); Stereotactic radiosurgery using γ-rays from radioactive Cobalt-60 installed in Gamma Knife (Elekta Instruments, Stockholm, Sweden)
No Intervention: observation

Outcome Measures

Primary Outcome Measures

1. Overall survival [36 months]

Secondary Outcome Measures

1. time to CNS progression [36 months]

2. time to symptomatic brain metastasis [36 months]

3. quality of life [36 months]

4. cause of death (neurologic vs. others) [36 months]

5. neurocognitive function [36 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 metastases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul,		Korea, Republic of

Sponsors and Collaborators

• Samsung Medical Center

Investigators

• Principal Investigator: Myungju Ahn, M.D., Ph.D., Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01130766
• Other Study ID Numbers: 2009-01-059
• First Posted: May 26, 2010
• Last Update Posted: May 26, 2010
• Last Verified: Apr 1, 2010

• Keywords provided by , ,: Non-small Cell Lung Cancer; Asymptomatic brain metastasis; Stereotactic radiosurgery (SRS)
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis

Study Results

No Results Posted as of May 26, 2010