Neurocognitive DeficitWHOBI-STERNCT04891471
WHOle Brain Irradiation or STEreotactic Radiosurgery for Five or More Brain Metastases (WHOBI-STER)
A study testing Stereotactic RadioTherapy and Whole Brain Irradiation in people with Neurocognitive Deficit and Quality of Life, run by Mediterranean Institute of Oncology at 4 sites in Italy.
Trial summary
This work aims to evaluate neurocognitive performance, daily activity and quality of life and local control among patients with brain metastasis (MBM) ≥ 5 due to solid tumors treated with Stereotactic RadioSurgery (SRS) or Whole Brain RadioTherapy (WBRT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurocognitive Deficit, Quality of Life, Activities of Daily Living
- What is being tested?
- Stereotactic RadioTherapy and Whole Brain Irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesItaly
- Study dates
- 15 Sep 2020to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18
- Life expectancy > 3 months
- Brain metastases number ≥ 5
- Primary tumor histologic diagnosis
- Complete Extracranial staging
- Montreal Cognitive Assessment ≥ 20/30
Show all 9Show fewer
- Barthel Activities of Daily Living ≥ 90/100
- KPS ≥ 70
- Signed Informed Consent
Who cannot join
- Brain-MRI contraindications
- Contraindications to SRS
- Pregnancy
- Hemorrhagic cerebral disease
- Miliary metastases
- Massive perilesional edema
Show all 15Show fewer
- Leptomeningeal involvement
- Previous brain irradiation
- Dementia
- Non-solid brain tumor
- Ischaemic event
- Alcohol and/or drugs abuse
- Anxiety and depression
- KPS ≤ 60
- Life expectancy < 3 months
Trial locations and contacts
4 sites in 1 country.
Italy4 sites, 4 recruiting
- Recruiting
Radiation Oncology Unit - Department of Biomedical, Dental Science and Morphological and Functional Images, University of Messina
Messina, 98125
Silvana Parisi, +393406284095, silvana.parisi@unime.it
Silvana Parisi, silvana.parisi@unime.it
- Recruiting
Radiation Oncology, ARNAS-Civico Hospital
Palermo, 90127
Gianluca Mortellaro, 3298811698, gianlucamortellaro@virgilio.it
Giuseppe Ferrera
- Recruiting
Fondazione Istituto Oncologico del Mediterraneo
Viagrande, Catania, 95029
Irene R. Cravagno, Chief Radiation Oncology Unit, irene_rita.cravagno@fondazioneiom.it
Anna Viola, Radiation Oncologist, anna.viola@fondazioneiom.it
- Recruiting
REM Radiotherapy (parent company of Mediterranean Institute of Oncology)
Viagrande, Catania, 95029
Gianluca Ferini, Chief Radiation Oncology Unit, +393311341117, gianluca.ferini@grupposamed.com
Gianluca Ferini
About this study
Official title: WHOle Brain Irradiation and STEreotactic Radiosurgery for Five or More Brain Metastases (WHOBI-STER): a Prospective Comparative Study of Neurocognitive Outcomes, Level of Autonomy in Daily Activities and Quality of Life
This work aims to evaluate neurocognitive performance, daily activity and quality of life and local control among patients with brain metastasis (MBM) ≥ 5 due to solid tumors treated with Stereotactic RadioSurgery (SRS) or Whole Brain RadioTherapy (WBRT). This multicentric randomised controlled trial will be conducted at the Fondazione IOM (Viagrande) in collaboration with REM (Viagrande), Hospital G. Martino (Messina) and Hospital Civico ARNAS (Palermo). It will involve, within 5 years starting from 15 September 2020, the enrollment of 100 patients (50 for each arm) with MBM ≥ 5, age ≥ 18 years, Karnofsky Performance Status (KPS) ≥ 70, life expectancy > 3 months, histological confirmation of primary tumor, with controlled or controllable extracranial disease, baseline Montreal Cognitive Assessment (MoCA) of 20/30, Barthel Activities of Daily Living score 90/100, to be subjected to SRS on each brain lesion by LINAC with monoisocentric technique and non-coplanar arcs (experimental arm) or to WBRT (control arm). The primary endpoints are neurocognitive performance, quality of life and autonomy in daily-life activities variations, the first one assessed by Moca Score and Hopkins Verbal Learning Test - Revised, the second one through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 Palliative Care (EORTC QLQ-C15-PAL) and Brain Neoplasm (BN-20) questionnaires, the third one through the Barthel Index, respectively. The secondary endpoints are time to intracranial failure, overall survival, retreatments frequency, acute and late toxicities, KPS decrease. It will be considered significant a statistical difference of at least 29% between the two arms (statistical power of 80% with a significance level of 95%). This trial has been approved by the local ethics committee on July 7th 2020 (record 70). Several studies debate what is the predominant factor accountable for the development of neurocognitive decay among patients undergoing brain irradiation for MBM: radiotherapy, especially if extended to the entire brain, or intracranial disease progression? Answer to this question may come from current opportunity, thanks to recent technological advancement, to treat, with significant time savings, improved patient comfort and at the same time minimizing the dose to healthy brain tissue, Multiple Brain Metastasis simultaneously, otherwise attackable only by panencephalic irradiation. The pursuit of a local control rate comparable to that obtainable with WBRT remains the fundamental prerequisite for the aforementioned related assessments.
- Being tested
- Stereotactic RadioTherapy, Whole Brain Irradiation
- Keywords
- multiple brain metastasis, neurocognitive decay, whole brain radiotherapy, stereotactic radiosurgery, stereotactic body radiotherapy, quality of life, solid tumor, Activities of Daily Living, best supportive care, palliative radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic RadioTherapyRadiation
Also called Stereotactic RadioSurgery, Stereotactic Body RadioTherapy
To treat only brain metastasis identified through Magnetic Resonance imaging by means of stereotactic radiotherapy (experimental intervention) to determine if sparing of clinically uninvolved brain implies a better neurocognitive performance, quality of life and level of autonomy in activities of daily living respect to Whole Brain Irradiation (active comparator).
Whole Brain IrradiationRadiation
Also called Whole Brain Radiotherapy, Panencephalic Radiotherapy
To irradiate the entire brain, site of at least 5 parenchymal metastasis.
| Study group | Role | What they receive |
|---|---|---|
| SRS/SBRT arm | Experimental | Patients with five or more brain metastasis assigned by randomization to Stereotactic RadioSurgery (SRS) or Stereotactic Body RadioTherapy (SBRT) will be treated with a highly-conformal metastasis-directed single dose between 15 and 24 Gy or fractionated dose (e.g. 27 Gy in 3 fractions), respectively, depending on lesion size, while sparing clinically negative brain. The treatment will be delivered using five non-coplanar arcs and a mono-isocentric technique. Receives: Radiation: Stereotactic RadioTherapy |
| WBI arm | Active comparator | Patients with five or more brain metastasis assigned by randomization to Whole Brain Irradiation (WBI) will be treated using a 3D-Conformal RadioTherapy technique for a uniform dose delivery of 30 Gy in 10 daily/fractions to the target, that is entire brain. Receives: Radiation: Whole Brain Irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive changes detected through Moca Score
To assess how neurocognitive performance changes after SRS/SBRT compared to WBI
Measured: Change from Baseline pre-Radiotherapy Neurocognitive Functional Status every three months after treatment through study completion, an average of 1 year
Changes of Autonomy in daily activities detected through the Barthel Index
To assess how level of autonomy in activities of daily living changes after SRS/SBRT compared to WBI
Measured: Change from Baseline pre-Radiotherapy Barthel Index every three months after treatment through study completion, an average of 1 year
Change in quality of life detected though the EORTC QLQ-C15-PAL questionnaire
To assess how quality of life changes after SRS/SBRT compared to WBI
Measured: Change from Baseline pre-Radiotherapy EORTC QLQ-C15-PAL questionnaire every three months after treatment through study completion, an average of 1 year
Neurocognitive changes detected through Hopkins Verbal Learning Test - Revised
To assess how neurocognitive performance changes after SRS/SBRT compared to WBI
Measured: Change from Baseline pre-Radiotherapy Neurocognitive Functional Status every three months after treatment through study completion, an average of 1 year
Change in quality of life detected though the BN-20 questionnaire
To assess how quality of life changes after SRS/SBRT compared to WBI
Measured: Change from Baseline pre-Radiotherapy BN-20 questionnaire every three months after treatment through study completion, an average of 1 year
Secondary outcomes (6)
Time to local failure
Time between treatment and cerebral disease progression detected through Magnetic Resonance imaging
Measured: every three months after treatment through study completion, an average of 1 year
Overall Survival
Time from the first day of treatment to exitus
Measured: after treatment completion through study completion, an average of 1 year
Re-treatment rate
Difference in needing further subsequent radiotherapy treatment between SRS/SBRT and WBI arms
Measured: after first treatment completion through study completion, an average of 1 year
Acute Central Nervous System (CNS) toxicities evaluated by means of Radiation Therapy Oncology Group (RTOG)/ European Organization for Research and Treatment of Cancer (EORTC) Radiation Toxicity Grading
Toxicities registered within three months from treatment
Measured: from treatment completion until three months later
Late Central Nervous System (CNS) toxicities evaluated by means of Radiation Therapy Oncology Group (RTOG)/ European Organization for Research and Treatment of Cancer (EORTC) Radiation Toxicity Grading
Toxicities registered after three months from treatment
Measured: from three months after treatment completion through study completion, an average of 1 year
Karnofsky Performance Status changing
Evaluation of how patient's performance status modifies after treatment
Measured: after treatment completion through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start15 Sep 2020
- Primary completion15 Sep 2025 (estimated)
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurocognitive DeficitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mediterranean Institute of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Messina, University of Palermo
- Responsible party
- Sponsor
- Investigators
- Gianluca Ferini, Principal investigator, REM Radiotherapy (parent company of Mediterranean Institute of Oncology)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891471
- Sponsor's protocol ID
- 70/2020/CECT2
- Acronym
- WHOBI-STER
- Status last verified
- Jan 2023
- First submitted
- 20 Apr 2021
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Ferini G, Viola A, Valenti V, Tripoli A, Molino L, Marchese VA, Illari SI, Rita Borzi G, Prestifilippo A, Umana GE, Martorana E, Mortellaro G, Ferrera G, Cacciola A, Lillo S, Pontoriero A, Pergolizzi S, Parisi S. Whole Brain Irradiation or Stereotactic RadioSurgery for five or more brain metastases (WHOBI-STER): A prospective comparative study of neurocognitive outcomes, level of autonomy in daily activities and quality of life. Clin Transl Radiat Oncol. 2021 Dec 2;32:52-58. doi: 10.1016/j.ctro.2021.11.008. eCollection 2022 Jan.
PubMed 34926839
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WHOle Brain Irradiation and STEreotactic Radiosurgery for Five or More Brain Metastases (WHOBI-STER): a Prospective Comparative Study of Neurocognitive Outcomes, Level of Autonomy in Daily Activities and Quality of Life
- ClinicalTrials.gov ID
- NCT04891471
- Acronym / sponsor ID
- WHOBI-STER / 70/2020/CECT2
- Keywords
- multiple brain metastasis, neurocognitive decay, whole brain radiotherapy, stereotactic radiosurgery, stereotactic body radiotherapy, quality of life, solid tumor, Activities of Daily Living
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mediterranean Institute of OncologyUniversity, hospital or other
- Collaborators
- University of Messina, University of Palermo
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This work aims to evaluate neurocognitive performance, daily activity and quality of life and local control among patients with brain metastasis (MBM) ≥ 5 due to solid tumors treated with Stereotactic RadioSurgery (SRS) or Whole Brain RadioTherapy (WBRT). This multicentric randomised controlled trial will be conducted at the Fondazione IOM (Viagrande) in collaboration with REM (Viagrande), Hospital G. Martino (Messina) and Hospital Civico ARNAS (Palermo). It will involve, within 5 years starting from 15 September 2020, the enrollment of 100 patients (50 for each arm) with MBM ≥ 5, age ≥ 18 years, Karnofsky Performance Status (KPS) ≥ 70, life expectancy > 3 months, histological confirmation of primary tumor, with controlled or controllable extracranial disease, baseline Montreal Cognitive Assessment (MoCA) of 20/30, Barthel Activities of Daily Living score 90/100, to be subjected to SRS on each brain lesion by LINAC with monoisocentric technique and non-coplanar arcs (experimental arm) or to WBRT (control arm). The primary endpoints are neurocognitive performance, quality of life and autonomy in daily-life activities variations, the first one assessed by Moca Score and Hopkins Verbal Learning Test - Revised, the second one through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 Palliative Care (EORTC QLQ-C15-PAL) and Brain Neoplasm (BN-20) questionnaires, the third one through the Barthel Index, respectively. The secondary endpoints are time to intracranial failure, overall survival, retreatments frequency, acute and late toxicities, KPS decrease. It will be considered significant a statistical difference of at least 29% between the two arms (statistical power of 80% with a significance level of 95%). This trial has been approved by the local ethics committee on July 7th 2020 (record 70). Several studies debate what is the predominant factor accountable for the development of neurocognitive decay among patients undergoing brain irradiation for MBM: radiotherapy, especially if extended to the entire brain, or intracranial disease progression? Answer to this question may come from current opportunity, thanks to recent technological advancement, to treat, with significant time savings, improved patient comfort and at the same time minimizing the dose to healthy brain tissue, Multiple Brain Metastasis simultaneously, otherwise attackable only by panencephalic irradiation. The pursuit of a local control rate comparable to that obtainable with WBRT remains the fundamental prerequisite for the aforementioned related assessments.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SRS/SBRT arm | Experimental | Radiation: Stereotactic RadioTherapyPatients with five or more brain metastasis assigned by randomization to Stereotactic RadioSurgery (SRS) or Stereotactic Body RadioTherapy (SBRT) will be treated with a highly-conformal metastasis-directed single dose between 15 and 24 Gy or fractionated dose (e.g. 27 Gy in 3 fractions), respectively, depending on lesion size, while sparing clinically negative brain. The treatment will be delivered using five non-coplanar arcs and a mono-isocentric technique. |
| WBI arm | Active comparator | Radiation: Whole Brain IrradiationPatients with five or more brain metastasis assigned by randomization to Whole Brain Irradiation (WBI) will be treated using a 3D-Conformal RadioTherapy technique for a uniform dose delivery of 30 Gy in 10 daily/fractions to the target, that is entire brain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age > 18
- Life expectancy > 3 months
- Brain metastases number ≥ 5
- Primary tumor histologic diagnosis
- Complete Extracranial staging
Key exclusion criteria (15 listed)
- Brain-MRI contraindications
- Contraindications to SRS
- Pregnancy
- Hemorrhagic cerebral disease
- Miliary metastases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic RadioTherapyAlso: Stereotactic RadioSurgery, Stereotactic Body RadioTherapyTo treat only brain metastasis identified through Magnetic Resonance imaging by means of stereotactic radiotherapy (experimental intervention) to determine if sparing of clinically uninvolved brain implies a better neurocognitive performance, quality of life and level of autonomy in activities of daily living respect to Whole Brain Irradiation (active comparator). | Radiation | SRS/SBRT arm |
| Whole Brain IrradiationAlso: Whole Brain Radiotherapy, Panencephalic RadiotherapyTo irradiate the entire brain, site of at least 5 parenchymal metastasis. | Radiation | WBI arm |
Primary outcome
Neurocognitive changes detected through Moca Score
Time frame: Change from Baseline pre-Radiotherapy Neurocognitive Functional Status every three months after treatment through study completion, an average of 1 year
To assess how neurocognitive performance changes after SRS/SBRT compared to WBI
Changes of Autonomy in daily activities detected through the Barthel Index
Time frame: Change from Baseline pre-Radiotherapy Barthel Index every three months after treatment through study completion, an average of 1 year
To assess how level of autonomy in activities of daily living changes after SRS/SBRT compared to WBI
Change in quality of life detected though the EORTC QLQ-C15-PAL questionnaire
Time frame: Change from Baseline pre-Radiotherapy EORTC QLQ-C15-PAL questionnaire every three months after treatment through study completion, an average of 1 year
To assess how quality of life changes after SRS/SBRT compared to WBI
Neurocognitive changes detected through Hopkins Verbal Learning Test - Revised
Time frame: Change from Baseline pre-Radiotherapy Neurocognitive Functional Status every three months after treatment through study completion, an average of 1 year
To assess how neurocognitive performance changes after SRS/SBRT compared to WBI
Change in quality of life detected though the BN-20 questionnaire
Time frame: Change from Baseline pre-Radiotherapy BN-20 questionnaire every three months after treatment through study completion, an average of 1 year
To assess how quality of life changes after SRS/SBRT compared to WBI
6 secondary outcomes
Time to local failure
Time frame: every three months after treatment through study completion, an average of 1 year
Overall Survival
Time frame: after treatment completion through study completion, an average of 1 year
Re-treatment rate
Time frame: after first treatment completion through study completion, an average of 1 year
Acute Central Nervous System (CNS) toxicities evaluated by means of Radiation Therapy Oncology Group (RTOG)/ European Organization for Research and Treatment of Cancer (EORTC) Radiation Toxicity Grading
Time frame: from treatment completion until three months later
Late Central Nervous System (CNS) toxicities evaluated by means of Radiation Therapy Oncology Group (RTOG)/ European Organization for Research and Treatment of Cancer (EORTC) Radiation Toxicity Grading
Time frame: from three months after treatment completion through study completion, an average of 1 year
Karnofsky Performance Status changing
Time frame: after treatment completion through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Derived from this study: PubMed 34926839Ferini G, Viola A, Valenti V, Tripoli A, Molino L, Marchese VA, Illari SI, Rita Borzi G, Prestifilippo A, Umana GE, Martorana E, Mortellaro G, Ferrera G, Cacciola A, Lillo S, Pontoriero A, Pergolizzi S, Parisi S. Whole Brain Irradiation or Stereotactic RadioSurgery for five or more brain metastases (WHOBI-STER): A prospective comparative study of neurocognitive outcomes, level of autonomy in daily activities and quality of life. Clin Transl Radiat Oncol. 2021 Dec 2;32:52-58. doi: 10.1016/j.ctro.2021.11.008. eCollection 2022 Jan.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gianluca Ferini principal investigator
REM Radiotherapy (parent company of Mediterranean Institute of Oncology)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic RadioTherapy and Whole Brain Irradiation in people with Neurocognitive Deficit and Quality of Life, run by Mediterranean Institute of Oncology at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gianluca Ferini (+393311341117, gianluca.ferini@grupposamed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurocognitive changes detected through Moca Score (time frame: Change from Baseline pre-Radiotherapy Neurocognitive Functional Status every three months after treatment through study completion, an average of 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04891471, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.