Chemotherapy With or Without Radiosurgery for Asymptomatic Oligo Brain Metastasis

Nonsmall 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: Recruiting

Administrative data

• NCT number: NCT01301560
• Other study ID #: 2008-05-024
• Status: Recruiting
• Phase: Phase 3
• First received: February 21, 2011
• Last updated: February 22, 2011
• Start date: June 2008

Study information

• Verified date: February 2011
• Source: Samsung Medical Center
• Contact: Myung-Ju Ahn, Pf
• Phone: 82-2-3410-3459
• Email: silkahn[@]skku.edu
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 176
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Nonsmall Cell Lung Cancer

Intervention

Radiation:
• Radiosurgery
Gamma knife surgery for asymptomatic oligo-metastasis to brain from NSCLC
• Observation
No local treatment

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		1 year after the enrollment of the last patient	No
Secondary	Time to CNS progression		1 year after the enrollment of the last patient	No