Chemotherapy With or Without Radiosurgery for Asymptomatic Oligo Brain Metastasis

Phase 3

• Conditions: Nonsmall Cell Lung Cancer
• Interventions: Radiation: Radiosurgery; Radiation: Observation

• Registration Number: NCT01301560
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Status Verified: 2011-02
• Study First Submitted: 2011-02-21
• Study First Submitted QC: 2011-02-22
• Last Update Submitted: 2011-02-22
• Study First Posted: 2011-02-23
• Last Update Posted: 2011-02-23
• Primary Completion: 2013-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 176

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiosurgery arm	Radiosurgery	Radiosurgery before palliative chemotherapy
Observation arm	Observation	No radiotherapy or local treatment until specific symptoms or sign developed

Primary Outcome Measures

Name	Time	Method
overall survival	1 year after the enrollment of the last patient

Secondary Outcome Measures

Name	Time	Method
Time to CNS progression	1 year after the enrollment of the last patient

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of