Chemotherapy With or Without Radiosurgery for Asymptomatic Oligo Brain Metastasis

Samsung Medical Center

Status and phase: Unknown; Phase 3

Conditions: Nonsmall Cell Lung Cancer

Treatments: Radiation: Radiosurgery; Radiation: Observation

Study type: Interventional

Funder types: Other

Identifiers

NCT01301560

2008-05-024

Details and patient eligibility

About

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.

Enrollment: 176 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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176 participants in 2 patient groups

Radiosurgery arm

Experimental group

Description:

Radiosurgery before palliative chemotherapy

Treatment:

Radiation: Radiosurgery

Observation arm

No Intervention group

Description:

No radiotherapy or local treatment until specific symptoms or sign developed

Treatment:

Radiation: Observation