Memory Preservation of Hippocampal Avoidance Whole Brain Radiotherapy

Brain Metastases Clinical Trial

Official title:

The Memory Preservation Study of Whole Brain Radiotherapy With Hippocampal Avoidance for Patients With Brain Metastases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03247127
• Other study ID #: KMUHIRB-E(II)20170081
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2018
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: Pen-Tzu Fang, MD
• Phone: 886-7-3121101
• Email: ptmonicafang[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aimed to investigate the memory preservation and neurocognitive function protection of hippocampal avoidance whole brain radiotherapy (HA-WBRT) among people who speak Mandarin Chinese or Taiwanese.

Description:

Brain metastasis is very common, about 30% incidence rate for all patients with a diagnosis of cancer. The rising incidence of brain metastasis is most likely due to recent advances in systemic therapy, and use of magnetic resonance imaging (MRI). The most common primary site is the lung followed by breast. One of the standard treatments is whole brain radiotherapy; it can prolong the decline of neurocognitive function and improve quality of life. However, it can also cause decline in neurocognitive function as a late sequela. Memory impairment is the main cognitive function that affected by radiotherapy, and the neuronal stem cells located at hippocampal subgranular zone are highly sensitive to radiotherapy. There have been large randomized trials confirming that by HA-WBRT, the neurocognitive function decline can be reclaimed. In Taiwan, HA-WBRT is a popular and emerging treatment. However, not much study focused on its effects on neurocognitive function. The study is aimed to objectively investigate the memory preservation and neurocognitive function protection of HA-WBRT in people speaking Mandarin Chinese or Taiwanese by utilizing neurocognitive function test and QoL questionnaire.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with brain metastases, the brain metastases are located 5mm outside the hippocampus

• Pathologically proven diagnosis of nonhematopoietic malignancy other than germ cell malignancy

• No psychologic disorders

• Radiation Therapy Oncology Group recursive partitioning analysis class I or II

• First or second language: Mandarin Chinese or Taiwanese

• Signed the inform consensus

Exclusion Criteria:

• Less than 20 years old

• Leptomeningeal metastases or hydrocephalus

• Previous radiotherapy to head and neck region

• Creatinine >1.5mg/dl

• More than 2 extracranial metastases

• Patients who cannot tolerate memory or neurocognitive function test or cannot complete QoL questionnaire

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis
• Neurocognitive Function

Intervention

Radiation:
• Hippocampal avoidance whole brain radiotherapy
Planning target volume(PTV) for whole brain is Whole brain parenchyma plus2mm margin excluding metastases and HA region, 30Gy in 10 fractions will be delivered to PTVwhole brain. Bilateral Hippocampus will be contoured according to Radiation Therapy Oncology Group 0933 and hippocampal avoidance region is Hippocampi + 5mm margin. According to Radiation Therapy Oncology Group 0933 trial, dose to 100% of the hippocampus could not exceed 9 Gy, and maximal hippocampal dose could not exceed 16 Gy; dose to 100% of the hippocampus exceeding 10 Gy

Locations

Country	Name	City	State
Taiwan	Fang, Pen-Tzu	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (8)

Aoyama H, Tago M, Kato N, Toyoda T, Kenjyo M, Hirota S, Shioura H, Inomata T, Kunieda E, Hayakawa K, Nakagawa K, Kobashi G, Shirato H. Neurocognitive function of patients with brain metastasis who received either whole brain radiotherapy plus stereotactic — View Citation

DeAngelis LM, Delattre JY, Posner JB. Radiation-induced dementia in patients cured of brain metastases. Neurology. 1989 Jun;39(6):789-96. — View Citation

Ghia A, Tomé WA, Thomas S, Cannon G, Khuntia D, Kuo JS, Mehta MP. Distribution of brain metastases in relation to the hippocampus: implications for neurocognitive functional preservation. Int J Radiat Oncol Biol Phys. 2007 Jul 15;68(4):971-7. Epub 2007 Ap — View Citation

Gondi V, Pugh SL, Tome WA, Caine C, Corn B, Kanner A, Rowley H, Kundapur V, DeNittis A, Greenspoon JN, Konski AA, Bauman GS, Shah S, Shi W, Wendland M, Kachnic L, Mehta MP. Preservation of memory with conformal avoidance of the hippocampal neural stem-cel — View Citation

Gondi V, Tolakanahalli R, Mehta MP, Tewatia D, Rowley H, Kuo JS, Khuntia D, Tomé WA. Hippocampal-sparing whole-brain radiotherapy: a "how-to" technique using helical tomotherapy and linear accelerator-based intensity-modulated radiotherapy. Int J Radiat O — View Citation

Gondi V, Tome WA, Marsh J, Struck A, Ghia A, Turian JV, Bentzen SM, Kuo JS, Khuntia D, Mehta MP. Estimated risk of perihippocampal disease progression after hippocampal avoidance during whole-brain radiotherapy: safety profile for RTOG 0933. Radiother Onc — View Citation

Gutiérrez AN, Westerly DC, Tomé WA, Jaradat HA, Mackie TR, Bentzen SM, Khuntia D, Mehta MP. Whole brain radiotherapy with hippocampal avoidance and simultaneously integrated brain metastases boost: a planning study. Int J Radiat Oncol Biol Phys. 2007 Oct — View Citation

Roman DD, Sperduto PW. Neuropsychological effects of cranial radiation: current knowledge and future directions. Int J Radiat Oncol Biol Phys. 1995 Feb 15;31(4):983-98. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of Memory immediate recall and delayed recall	The memory battery is using Wechsler Memory Scale (Chinese), including Logical Memory I & II, Word Lists ? & II, Faces ? and spatial span.	From baseline to 4 months after RT complete, tests are performed at baseline before radiotherapy begins, 2 months after radiotherapy complete and 4 months after radiotherapy complete.
Primary	Changes of general cognitive function	General cognitive function are tested using cognitive abilities screening instrument, CASI for screening and to test cognitive function as a whole.	From baseline to 4 months after RT complete, tests are performed at baseline before radiotherapy begins, 2 months after radiotherapy complete and 4 months after radiotherapy complete.
Secondary	Changes of Quality of life	Quality of life are assessed using The Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire	From baseline to 4 months after RT complete, the participants are requested to fill in the questionnaire of quality of life at baseline before radiotherapy begins, and 2 months after radiotherapy complete and 4 months after radiotherapy complete.