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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 by invite only)
Both
Non-small 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:



- 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall survival

Outcome Time Frame:

36 months

Safety Issue:

No

Principal Investigator

Myungju Ahn, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Samsung Medical Center

Authority:

Korea: Food and Drug Administration

Study ID:

2009-01-059

NCT ID:

NCT01130766

Start Date:

June 2008

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non-small Cell Lung Cancer
  • Asymptomatic brain metastasis
  • Stereotactic radiosurgery (SRS)
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Metastasis

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