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

Brain Metastases Clinical Trial

— KROG17-06  

Official title:

A Phase II Multi-institutional Study of Hippocampus-sparing Whole Brain Radiotherapy and Simultaneous Integrated Boost for Multiple Brain Metastases From Non-small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03366376
• Other study ID #: 2017-08-070
• Status: Recruiting
• Phase: Phase 2
• First received: December 3, 2017
• Last updated: December 7, 2017
• Start date: December 11, 2017
• Est. completion date: December 1, 2019

Study information

• Verified date: December 2017
• Source: Samsung Medical Center
• Contact: Yong Chan Ahn, MD, PhD
• Phone: +82-2-3410-2602
• Email: ycahn.ahn[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis

Intervention

Radiation:
• WBRT with hippocampus-sparing and SIB
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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Korean Radiation Oncology Group

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intracranial progression free survival	Time from the date of start of radiotherapy to the date of death or intracranial progression	until 12 months
Secondary	Verbal neurocognitive function (Seoul Verbal Learning Test-Elderly, SVLT-E)	The relative decline in SVLT-E score from baseline to below time frame; ?SVLT = (SVLTB - SVLTF) ÷ SVLTB, where B=baseline and F=follow-up.	3,6,12 months
Secondary	Overall survival	Time from the date of start of radiotherapy to the date of death from any cause	until 12 months
Secondary	Adverse events	CTCAE v4.03	3,6,12 months
Secondary	Quality of life	EORTC QLQ-C30 and BN20	3,6,12 months