Hippocampus-sparing WBRT and Simultaneous Integrated Boost for Multiple Brain Metastases From NSCLC

NCT03366376 | Unknown Phase 2

• 1 other identifier: 2017-08-070
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Metastases

Keywords

hippocampus; radiotherapy

Outcome Measures

Primary Outcomes (1)

• Intracranial progression free survival

  Time from the date of start of radiotherapy to the date of death or intracranial progression

  until 12 months

Secondary Outcomes (4)

• Verbal neurocognitive function (Seoul Verbal Learning Test-Elderly, SVLT-E)

  3,6,12 months

• Overall survival

  until 12 months

• Adverse events

  3,6,12 months

• Quality of life

  3,6,12 months

Study Arms (1)

Experimental

EXPERIMENTAL

WBRT with hippocampus-sparing and SIB

Radiation: WBRT with hippocampus-sparing and SIB

Interventions

WBRT with hippocampus-sparing and SIB RADIATION

Radiotherapy could be delivered in 5, 8, or 10 fractions according to participating investigator's choice. The prescribed doses are as below; Fractions 5fxs 8fxs 10fxs Whole brain 20 Gy 24 Gy 25 Gy Gross tumor 30 Gy 40 Gy 40 Gy

Experimental

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically proven diagnosis of primary non-small cell lung cancer
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead
• Korean Radiation Oncology Group: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Yong Chan Ahn, MD, PhD

CONTACT

+82-2-3410-2602; ycahn.ahn@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2017
• First Posted: December 8, 2017
• Study Start: December 11, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 8, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)