Chemotherapy With or Without Radiosurgery for Asymptomatic Oligo Brain Metastasis

February 22, 2011 updated by: Samsung Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

176

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiosurgery arm
Radiosurgery before palliative chemotherapy
Radiation: Radiosurgery
Gamma knife surgery for asymptomatic oligo-metastasis to brain from NSCLC
No Intervention: Observation arm
No radiotherapy or local treatment until specific symptoms or sign developed
Radiation: Observation
No local treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 1 year after the enrollment of the last patient
1 year after the enrollment of the last patient

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to CNS progression
Time Frame: 1 year after the enrollment of the last patient
1 year after the enrollment of the last patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Anticipated)

May 1, 2013

Study Registration Dates

First Submitted

February 21, 2011

First Submitted That Met QC Criteria

February 22, 2011

First Posted (Estimate)

February 23, 2011

Study Record Updates

Last Update Posted (Estimate)

February 23, 2011

Last Update Submitted That Met QC Criteria

February 22, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-05-024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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