Memory Preservation of Hippocampal Avoidance Whole Brain Radiotherapy

NCT03247127 | Unknown DMC

• 1 other identifier: KMUHIRB-E(II)20170081
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain Metastases; Neurocognitive Function

Keywords

hippocampal avoidance whole brain radiotherapy (HA-WBRT); brain metastases; memory preservation; neurocognitive function

Outcome Measures

Primary Outcomes (2)

• Changes of Memory immediate recall and delayed recall

  The memory battery is using Wechsler Memory Scale (Chinese), including Logical Memory I \& II, Word Lists Ⅰ \& II, Faces Ⅰ 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.

• 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 Outcomes (1)

• Changes of Quality of life

  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.

Study Arms (1)

HA-WBRT

OTHER

Patients with brain metastases outside a 5-mm margin around either hippocampus and are eligible to this study will receive hippocampal avoidance whole brain radiotherapy 30 gray (Gy) in 10 fractions. The primary endpoint is Wechsler Memory Scale (Chinese) and cognitive abilities screening instrument (CASI) at 4 months.

Radiation: Hippocampal avoidance whole brain radiotherapy

Interventions

Hippocampal avoidance whole brain radiotherapy RADIATION

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

HA-WBRT

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Fang, Pen-Tzu

Kaohsiung City, 80660, Taiwan

RECRUITING

Related Publications (8)

• 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-cell compartment during whole-brain radiotherapy for brain metastases (RTOG 0933): a phase II multi-institutional trial. J Clin Oncol. 2014 Dec 1;32(34):3810-6. doi: 10.1200/JCO.2014.57.2909. Epub 2014 Oct 27.

  PMID: 25349290 RESULT

• 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 radiosurgery or radiosurgery alone. Int J Radiat Oncol Biol Phys. 2007 Aug 1;68(5):1388-95. doi: 10.1016/j.ijrobp.2007.03.048.

  PMID: 17674975 RESULT

• 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. doi: 10.1016/0360-3016(94)00550-8.

  PMID: 7860415 RESULT

• DeAngelis LM, Delattre JY, Posner JB. Radiation-induced dementia in patients cured of brain metastases. Neurology. 1989 Jun;39(6):789-96. doi: 10.1212/wnl.39.6.789.

  PMID: 2725874 RESULT

• Ghia A, Tome 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. doi: 10.1016/j.ijrobp.2007.02.016. Epub 2007 Apr 18.

  PMID: 17446005 RESULT

• 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 Oncol. 2010 Jun;95(3):327-31. doi: 10.1016/j.radonc.2010.02.030. Epub 2010 Apr 12.

  PMID: 20392503 RESULT

• Gondi V, Tolakanahalli R, Mehta MP, Tewatia D, Rowley H, Kuo JS, Khuntia D, Tome WA. Hippocampal-sparing whole-brain radiotherapy: a "how-to" technique using helical tomotherapy and linear accelerator-based intensity-modulated radiotherapy. Int J Radiat Oncol Biol Phys. 2010 Nov 15;78(4):1244-52. doi: 10.1016/j.ijrobp.2010.01.039.

  PMID: 20598457 RESULT

• Gutierrez AN, Westerly DC, Tome 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 1;69(2):589-97. doi: 10.1016/j.ijrobp.2007.05.038.

  PMID: 17869672 RESULT

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

Study Officials

• Pen-Tzu Fang, MD

  Department of Radiation Oncology, Kaohsiung Medical University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pen-Tzu Fang, MD

CONTACT

886-7-3121101; ptmonicafang@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Hippocampal avoidance -whole brain radiotherapy(HA-WBRT), which delivers radiation to whole brain and moreover, to reduce mean dose to hippocampal neural stem-cell compartment to minimize the neurocognitive function impairment

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 11, 2017
• Study Start: March 27, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: August 28, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)