To hear about similar clinical trials, please enter your email below

Trial Title: Chemotherapy With or Without Radiosurgery for Asymptomatic Oligo Brain Metastasis

NCT ID: NCT01301560

Condition: Nonsmall Cell Lung Cancer

Conditions: Official terms:
Lung Neoplasms
Neoplasm Metastasis
Carcinoma, Non-Small-Cell Lung

Conditions: Keywords:
Asymptomatic brain metastasis
NSCLC
GKS

Study type: Interventional

Study phase: Phase 3

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: Radiosurgery
Description: Gamma knife surgery for asymptomatic oligo-metastasis to brain from NSCLC
Arm group label: Radiosurgery arm

Intervention type: Radiation
Intervention name: Observation
Description: No local treatment
Arm group label: Observation arm

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Samsung Medical Center

Address:
City: Seoul
Zip: 135-710
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Myung-Ju Ahn, Pf

Phone: 822-3410-3459
Email: silkahn@skku.edu

Start date: June 2008

Lead sponsor:
Agency: Samsung Medical Center
Agency class: Other

Source: Samsung Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01301560

Login to your account

Did you forget your password?