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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Nonsmall Cell Lung Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

overall survival

Outcome Time Frame:

1 year after the enrollment of the last patient

Safety Issue:

No

Authority:

Korea: Food and Drug Administration

Study ID:

2008-05-024

NCT ID:

NCT01301560

Start Date:

June 2008

Completion Date:

Related Keywords:

  • Nonsmall Cell Lung Cancer
  • Asymptomatic brain metastasis
  • NSCLC
  • GKS
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Metastasis

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