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RecruitingNCT04805255HF-SRTUpdated May 1, 2023

A Neurocognitive Study in Patients With Brain Oligometastases Receiving Hypofractionated SRT

An observational study in Brain Metastases, Adult, sponsored by Chang Gung Memorial Hospital. Recruiting at 2 sites in Taiwan. Open to participants aged 18 Years to 84 Years. Per ClinicalTrials.gov, last updated 2023-05-01.

Sponsored by Chang Gung Memorial Hospital · Observational

From the registry’s dates

  • Started Feb 2021; still recruiting 5 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
135
Ages
18 Years to 84 Years
Sex
All
01

Study summary

Background:

For newly-diagnosed patients with brain metastasis, conventional whole-brain radiation therapy (WBRT) might still remain a common palliative management even for those with brain oligometastases. However, WBRT-related late consequences, particularly a decline in neurocognitive functions (NCFs), are a major concern. Actually, WBRT-related neurocognitive dysfunction is usually characterized as deterioration involving learning and memory, in which the extremely radiosensitive hippocampus indeed plays a critical role. In order to postpone or mitigate the effect of conventional WBRT-induced neurocognitive impairments, there have been some strategies and options in clinical practice. Among them, the technique of highly precise and accurate stereotactic radiosurgery or stereotactic radiotherapy (i.e., hypofractionated stereotactic radiotherapy, HS-SRT) might have been widely administered in irradiating purely focal metastatic foci in cancer patients with a limited number of brain metastases.

Methods:

Newly-diagnosed cancer patients harboring 1-3 brain metastatic lesions are eligible if they are still in a fair/good performance status. All recruited patients should receive baseline brain MRI examination and pre-radiotherapy neurocognitive assessment. Sticking to the principles of stereotactic radiosurgery/radiotherapy (SRS/SRT), treatment planning will be designed via the technique of volumetric-modulated arc therapy (VMAT) to achieve both satisfactory in-field local control (but assuring of hippocampal avoidance) and a tolerably low incidence of radiation necrosis, a course of hypofractionated stereotactic radiotherapy (HF-SRT) is delivered within 2 weeks with a cumulative dose of 3000 - 3500 cGy in 5 fractions. Accordingly, a battery of neuropsychological measures, which includes 7 standardized neuropsychological tests (e.g., executive functions, verbal and non-verbal memory, working memory, and psychomotor speed), is used to evaluate neurocognitive functions for our registered patients. The primary outcome measure is cognitive-deterioration-free survival, which is defined mainly as the time from enrollment to a NCF decline of exceeding than 1 SD away from the baseline involving at least one of the assessed NCF tests. Additionally, patients who expire before 6 months or are alive but fail to undergo all the neurocognitive testing administered would also be defined as suffering from cognitive deterioration. There are quite a few secondary endpoints of interest, including the patterns of (CNS) failure, actual local control rates, time to (CNS) progression, and cumulative incidence of radiation necrosis.

Expected results:

This prospective neurocognitive study aims to examine thoroughly the impact of the technique of highly focal brain irradiation administered with a course of hypofractionated SRT delivered to brain metastatic lesions merely (but sparing hippocampal structures), on neurocognitive performance, time to (CNS) progression, and patterns of (CNS) failure, in patients with brain oligometastases and a fair/good performance status. It is anticipated that (in-field) local control would be durable and that neurocognitive outcomes would also be maintained favorably. Moreover, we also expect that the patterns of (CNS) failure and the individual time to progression will be clearly demonstrated in this prospective longitudinal neurocognitive study.

02

Conditions studied

  • Brain Metastases, Adult

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Keywords

  • Brain Oligometastases
  • Stereotactic Radiotherapy (SRT)
  • Hypofractionation
  • Hypofractionated Stereotactic Radiotherapy (HF-SRT)
  • Neurocognitive Functions (NCFs)
  • Time to Progression (TTP)
  • Time to CNS Progression
  • Progression-free Survival (PFS)
  • Hippocampus
  • CNS Patterns of Failure
  • Radiation Necrosis
03

In context

Brain Neoplasms

1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.

This study's planned enrollment of 135 is above the median of 100 across 380 observational studies indexed under Brain Neoplasms.

Browse Brain Neoplasms studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 84 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with newly-diagnosed brain oligometastases and an acceptable performance status would receive baseline neurocognitive assessment.

Inclusion criteria

  • Patients with pathologically-confirmed non-hematopoietic malignancy who are referred for postoperative adjuvant or therapeutic hypofractionated stereotactic radiotherapy (HF-SRT).
  • A Fair/good performance status no worse than Eastern Cooperative Group (ECOG) of 2 or an acceptable performance status of Karnofsky Score (KPS) at least 70.
  • The number and extent of brain metastatic lesions should be no more than three metastatic foci with a greatest diameter no more than 4 cm shown on pre-radiotherapy MRI; namely, that is the clinical setting of oligometastatic brain disease or brain oligometastases.

Exclusion criteria

Exclusion Criteria:

  • Patients with their primary cancer arising from hematological malignancies (i.e., malignant lymphomas, leukemia), germ cell tumors, or malignant meningiomas
  • Patients with MRI-identified metastasis within 5 mm peri-hippocampally
  • Patients with metastasis involving the brain stem
  • Clinical suspicion of leptomeningeal spreading
  • History of prior radiotherapy including stereotactic radiosurgery delivered to brain/head region for any reasons
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
135 participants (estimated)
Patient registry
No

Groups and cohorts

  • Hypofractionated Stereotactic Radiotherapy (HF-SRT)

    A prospective cohort study addressing both neurocognitive outcome measures and oncological endpoints will be carried out for treating newly-diagnosed brain oligometastases with a pre-defined course of hypofractionated stereotactic radiotherapy (HF-SRT) in cancer patients with a fair/satisfactory performance status. Either a limited number of brain metastases or oligometastatic brain disease refers to that the number of brain metastatic lesions (both post-resected and intact) at enrollment should be limited to three or fewer and that the greatest diameter of any metastatic lesion (either a tumor bed post-surgical resection or an intact brain metastasis) should be no more than 4 cm.

    Radiation: Hypofractionated Stereotactic Radiotherapy

Interventions

  • RadiationHypofractionated Stereotactic Radiotherapy

    A course of hypofractionated stereotactic radiotherapy (HF-SRT) is delivered within 2 weeks with a cumulative dose of 3000 - 3500 cGy in 5 fractions.

06

What researchers measure

Primary outcomes

  1. The cognitive-deterioration-free survival

    The time from enrollment to a decline of exceeding than 1SD away from the baseline in at least one of the assessed NCF tests. Furthermore, regarding cognitive-deterioration-free survival, patients who expire before 6 months or are alive but do not undergo all the neurocognitive testing administered or even fail to receive MMSE evaluation would be assumed reasonably that they suffer cognitive deterioration at the time of death or at the time point, or they fail to receive their first neurocognitive assessment follow-up as long as there are no subsequent NCF assessments.

    Time frame: from baseline up to 24 months

Secondary outcomes

  1. Overall survival (OS) or Median survival time (MST)

    Time frame: up to 24 months

  2. Patterns of CNS failure

    1. In-field (brain) local recurrence: Local surgical bed recurrence Local recurrence of unresected metastases (The individual time to event is the time from study enrollment to recurrence at the local surgical bed, and the time from enrollment to progression of intact metastases, respectively.) 2. Distant (brain) parenchymal progression 3. Development of leptomeningeal disease (LMD)

    Time frame: up to 24 months

  3. Time to progression (TTP)

    Time frame: up to 24 months

  4. Progression-free survival (PFS)

    Time frame: up to 24 months

07

Study locations

2 of 2 sites recruiting
  • Chang Gung Memorial Hospital
    Taoyuan, 333, Taiwan
    Recruiting
  • Chang Gung Memorial Hospital
    Taoyuan, 333, Taiwan
    • Shinn-Yn Lin, M.D. · Contact · 886-33281200
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04805255
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Sponsor
First posted
Mar 18, 2021
Start date
Feb 25, 2021
Primary completion
Mar 10, 2027 (estimated)
Completion
Mar 10, 2027 (estimated)
Last update
May 1, 2023

Study contacts

Chi-Cheng Chuang, M.D.
Contact
ccc2915@cgmh.org.tw
+886-33281200 ext. 2412
Shinn-Yn Lin, M.D.
Contact
rt3126@cgmh.org.tw
+886-33281200 ext. 7000

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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