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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05477316
Other study ID # 0930-20
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 11, 2021
Est. completion date December 2024

Study information

Verified date July 2022
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A single-arm pilot study, to assess the efficacy of cerebellar IMRT combined with cerebral SRS in patients with brain metastases that are predominantly in the posterior fossa - a novel treatment approach


Description:

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Study Design


Intervention

Radiation:
Radiation treatment
Radiation treatment of IMRT to the cerebellum and SRS to the cerebrum

Locations

Country Name City State
Israel Hadassah Ein Kerem Medical Center Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (21)

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Outcome

Type Measure Description Time frame Safety issue
Primary Brain control: Central Nervous System (CNS)- Progression Free Survival (PFS) Metastatic brain lesions treated with IMRT/SRS will be tracked and measured using MRI. Disease in the brain and systemically will be assessed by RECIST. Change in lesion size in the whole body will be followed and assessed at screen, 2 month after radiation treatment, then every 3 month until the date of first documented progression or date of death from any cause, up to 10 years.
Secondary Cognitive function Patient cognitive function will improve after study treatment (Hopkines verbal learning test (HVLT), Trail Making Test (TMT) A + B, Controlled Oral Word Association Test (COWAT) and clock drawing test). Cognitive functions will be univariately compared between the groups using the Student's t-test or the Mann-Whitney Ranks test. We will also perform multivariate analyses using either linear regression of Poisson regression, depending on the outcomes distribution. Change in patient cognitive function will be followed and assessed at screen, 2 month after radiation treatment, then every 3 month, until the date of first documented progression or date of death from any cause, up to 10 years.
Secondary Quality of life (QOL) Patient QOL will improve after study treatment. QOL will be evaluated due to score in four questionnaires: European Organisation for. Research and Treatment of Cancer (EORTC) QLQ C30, The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT), The Pittsburgh Sleep Quality Index (PSQI) and Hospital Anxiety and Depression Scale (HADS). Cognitive functions will be univariately compared between the groups using the Student's t-test or the Mann-Whitney Ranks test. We will also perform multivariate analyses using either linear regression of Poisson regression, depending on the outcomes distribution. Change in patient QOL will be followed and assessed at screen, 2 month after radiation treatment, then every 3 month, until the date of first documented progression or date of death from any cause, up to 10 years.
Secondary Overall survival (OS) Patient OS will be assessed via timely patient follow-ups on survival status Status will be checked at every visit and follow up, until the date of death from any cause, up to 10 years.
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