Hippocampus-sparing WBRT and Simultaneous Integrated Boost for Multiple Brain Metastases From NSCLC (KROG17-06)

Samsung Medical Center

Status and phase: Unknown; Phase 2

Conditions: Brain Metastases

Treatments: Radiation: WBRT with hippocampus-sparing and SIB

Study type: Interventional

Funder types: Other

Identifiers

NCT03366376

2017-08-070

Details and patient eligibility

About

This study evaluates hippocampus-sparing whole-brain radiotherapy with simultaneous integrated boost for patients with multiple brain metastases from non-small cell lung cancer. The primary endpoint is intracranial progression free survival, and secondary endpoints are verbal neurocognitive function, overall survival, adverse events according to CTCAE v4.03, and quality of life.

Enrollment: 80 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathologically proven diagnosis of primary non-small cell lung cancer
• 3 or more measurable brain metastasis ≥3 mm outside a 5-mm margin around either hippocampus on gadolinium contrast enhanced MRI within 14 days prior to registration
• KPS ≥70
• Age ≥55 years
• Informed consent prior to study entry

Exclusion criteria

• Patients with leptomeningeal metastases
• ≥3 organ sites of extracranial metastases (including lung-to-lung metastases) within 3 months
• Contraindication to MRI such as implanted metal devices or foreign bodies
• Prior radiation therapy (including SRS) to the brain

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Experimental

Experimental group

Description:

WBRT with hippocampus-sparing and SIB

Treatment:

Radiation: WBRT with hippocampus-sparing and SIB