Hippocampal-Sparing Stereotactic Radiosurgery Treatment of Brain Metastases Using CyberKnife

NCT05177185 | Unknown Phase 2

• 1 other identifier: 20200253-01H
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

This phase II clinical trial involves the use of hippocampal-sparing together with stereotactic radiosurgery (SRS) for the treatment of brain metastases. The standard of care in the treatment of brain metastases is cranial radiation, but this can be associated with significant neurocognitive sequelae, including reduced verbal memory, spatial memory, attention and problem solving. This can be minimized with the use of SRS, rather than whole brain radiotherapy (WBRT). Additionally, some of the neurotoxicity has been linked to damage in neural progenitor cells contained within the hippocampus. A recent phase III clinical trial has demonstrated reduced neurocognitive decline with use of hippocampal-sparing techniques in WBRT. This trial aims to see if this can be further improved by combining SRS and hippocampal-sparing.

Conditions

Brain Metastases; Radiosurgery

Keywords

Hippocampal-sparing

Outcome Measures

Primary Outcomes (1)

• Time to Neurocognitive Failure

  Neurocognitive failure is defined as the first failure, defined as a neurocognitive decline in at least one of the following tests; Hopkins Verbal Learning Test for total recall, delayed recall and delayed recognition; Controlled oral word association; Trail making tests part A and B; Brief visuospatial memory test revised.

  Baseline, 3 months, 6 months, 12 months (+/- 2 weeks)

Secondary Outcomes (5)

• Rate of Neurocognitive Preservation

  Baseline, 3 months, 6 months, 12 months (+/- 2 weeks)

• Change from M.D. Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score

  Baseline, 3 months, 6 months, 12 months (+/- 2 weeks)

• Intracranial Progression-Free Survival

  Baseline, 3 months, 6 months, 12 months (+/- 2 weeks)

• Overall Survival

  Baseline, 3 months, 6 months, 12 months (+/- 2 weeks)

• Number of Patients with Grade3+ Adverse Event

  Baseline, 3 months, 6 months, 12 months (+/- 2 weeks)

Study Arms (1)

SRS with hippocampal-sparing

EXPERIMENTAL

Stereotactic radiosurgery with hippocampal-sparing

Radiation: Hippocampal-sparing; Radiation: Stereotactic radiosurgery

Interventions

Hippocampal-sparing RADIATION

Dose constraint placed on hippocampi to minimize dose to hippocampi, while maintaining target coverage (at least 98% of brain metastasis volume must receive 100% of prescription dose).

SRS with hippocampal-sparing

Stereotactic radiosurgery RADIATION

Stereotactic radiosurgery (SRS) with prescription dose determined based on size of brain metastasis; 21 or 24 Gy in a single fraction if less than or equal to 20 mm, 18Gy in a single fraction in 21 - 30 mm, 15 Gy in a single fraction or 30 Gy in 5 fractions if 31 - 40 mm (physician discretion).

Also known as: SRS, Stereotactic radiotherapy

SRS with hippocampal-sparing

Eligibility Criteria

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

You may qualify if:

• years of age or older
• Either gender
• Patients must provide informed consent prior to registration
• Pathologically (histologically or cytologically) proven diagnosis of solid tumor malignancy
• Brain metastase(s) outside a 5-mm margin around either hippocampus
• Brain metastase(s) must be visible on contrast-enhanced magnetic resonance imaging (MRI); an allowed exception for patients who had undergone radiosurgery or surgical resection and are planning adjuvant radiotherapy do not have to have visible disease.
• Patients must have a gadolinium contrast-enhanced three-dimensional MRI scan, whether diagnostic or a MR simulation scan
• Karnofsky performance status of \>= 70 or ECOG \>= 2
• Patients may have had prior therapy for brain metastasis, including radiosurgery, as long as with hippocampal-sparing, and surgical resection; patients must have completed prior therapy (no specific time lapse between prior treatment and this treatment)

You may not qualify if:

• Prior external beam radiation therapy to the brain or whole brain radiation therapy, unless radiosurgery with hippocampal-sparing
• Radiographic evidence of hydrocephalus or other architectural distortion of the ventricular system, including placement of external ventricular drain or ventriculoperitoneal shunt
• Patients with definitive leptomeningeal metastases
• Contraindication to magnetic resonance (MR) imaging such as implanted metal devices or foreign bodies
• Contraindication to gadolinium contrast administration during MR imaging, such as allergy or insufficient renal function

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Related Publications (1)

• Brown PD, Gondi V, Pugh S, Tome WA, Wefel JS, Armstrong TS, Bovi JA, Robinson C, Konski A, Khuntia D, Grosshans D, Benzinger TLS, Bruner D, Gilbert MR, Roberge D, Kundapur V, Devisetty K, Shah S, Usuki K, Anderson BM, Stea B, Yoon H, Li J, Laack NN, Kruser TJ, Chmura SJ, Shi W, Deshmukh S, Mehta MP, Kachnic LA; for NRG Oncology. Hippocampal Avoidance During Whole-Brain Radiotherapy Plus Memantine for Patients With Brain Metastases: Phase III Trial NRG Oncology CC001. J Clin Oncol. 2020 Apr 1;38(10):1019-1029. doi: 10.1200/JCO.19.02767. Epub 2020 Feb 14.

  PMID: 32058845 BACKGROUND

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Design

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

Model Details: All patients will undergo hippocampal-sparing stereotactic radiosurgery

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 4, 2022
• Study Start: April 1, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2024
• Last Updated: February 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share