Brain MetastasesNCT05477316
A Study to Assess the Efficacy of Cerebellar IMRT Combined With Cerebral SRS in Patients With Brain Metastases
A study testing Radiation treatment in people with Brain Metastases and Posterior Fossa Lesion, run by Hadassah Medical Organization at 1 site in Israel.
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 Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Brain Metastases, Posterior Fossa Lesion, Cerebral Lesion
- What is being tested?
- Radiation treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteIsrael
- Study dates
- 11 Feb 2021to Dec 2024
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of multiple brain metastasis, predominantly in the posterior fossa: more than 5 metastases in the cerebellum, and less than 10 metastases in the cerebrum, visible on MRI, regardless of tumor origin.
- Provided written informed consent.
- Be male or female and at least 18 years of age on the day of signing informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- A minimum life expectancy of at least 3 months
- Female patients:
Show all 11Show fewer
- Willing to use adequate contraceptive measures until 6 weeks after the final dose of study treatment
- Not breast feeding
- Have a negative pregnancy test prior to the start of dosing if of childbearing potential or have evidence of non-childbearing potential by fulfilling one of the following criteria at screening:
- i. Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments ii. Women under 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with Luteinizing Hormone (LH) and Follicle-Stimulating Hormone (FSH) levels in the post-menopausal range for the institution iii. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation
- Male patients who are willing to use barrier contraception (i.e. condoms) until 4 months after the final dose of study treatment.
Who cannot join
- Prior treatment with Whole brain radiation (WBRT) (previous SRS is allowed for limited, up to 4 metastases, six month or more prior to the study treatment, and the index metastases should be all new)
- An investigational drug within five half-lives of the compound.
- Spinal cord compression unless asymptomatic and stable.
- Leptomeningeal disease.
- Moderate or severe symptomatic brain metastases defined as per Radiation therapy Oncology Group acute morbidity grade 3 to 4.
- Note: Grade 3 refers to neurological findings requiring hospitalization for initial management. Grade 4 refers to serious neurological impairment including paralysis, coma or seizures more than three times per week despite medication and requires hospitalization.
Show all 9Show fewer
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
- Involvement in the planning and conduct of the study
- Judgement by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Ein Kerem Medical Center
Jerusalem, 9112001
Amichay Meirovitz, MD, MBA, 972-26776735, amichaym@hadassah.org.il
Philip Blumenfeld, MD, philipb@hadassah.org.il
About this study
Official title: 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
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
Read the detailed description
This study includes patients with brain metastases, presenting with more than 5 cerebellar lesions and less than 10 cerebral lesions. This is a pilot study assessing the efficacy of a novel, combined treatment approach involving Intensity-modulated Radiation Therapy (IMRT)/ Volumetric Modulated Arc Therapy (VMAT), with or without integrated boost to metastases, administered to the posterior fossa, and Stereotactic Radiosurgery (SRS) administered to cerebral lesions. This is opposed to the current recommended treatment approach for such cases, being whole brain radiotherapy (WBRT). While an effective treatment with respect to lesion control, WBRT is not ideal as the total deliverable dose is limited to 30 Gy due to toxicity. In addition, this technique is responsible for major side effects, especially neurocognitive deterioration.
There are select cases of multiple brain metastases which are predominantly found in the posterior fossa. Rectal cancer is one such notorious example, however this type of spread is not limited to one region.
The investigators hypothesize that utilizing the novel combinational treatment approach of IMRT and SRS in cerebral and cerebellar brain metastases will improve long term brain control, maintain the patients' cognitive function and potentially improve overall survival, as the need for potent WBRT will become obsolete.
Patients with multiple brain metastases present in the cerebrum and cerebellum will be treated with SRS and IMRT respectively, simultaneously (within 3 weeks of one another). Brain MRI scans will be performed before commencement of the novel treatment approach, at two month after RT, and then every 3 months, or as indicated clinically, after treatment start. Concurrently at each MRI scan time point, patients will be assessed based on brain and whole-body metastatic progression by RECIST. Patients will also be assessed for central nervous system (CNS) - progression free survival (PFS) and body-PFS, cognitive function, quality of life and overall survival status via standardized follow-up tests.
- Conditions
- Brain Metastases, Posterior Fossa Lesion, Cerebral Lesion
- Being tested
- Radiation treatment
- Keywords
- Brain Metastases, Posterior Fossa, Cerebellum, Cerebral Lesion, Cerebrum
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation treatmentRadiation
Radiation treatment of IMRT to the cerebellum and SRS to the cerebrum
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Intensity-modulated Radiation Therapy (IMRT)/VMAT with integrated boost to the cerebellum and metastases and Stereotactic Radiosurgery (SRS) to the cerebral metastases as a novel treatment combination for brain metastases Receives: Radiation: Radiation treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (3)
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.
Measured: 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.
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.
Measured: 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.
Overall survival (OS)
Patient OS will be assessed via timely patient follow-ups on survival status
Measured: Status will be checked at every visit and follow up, until the date of death from any cause, up to 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start11 Feb 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meirrovitz Amichay, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477316
- Sponsor's protocol ID
- 0930-20
- Status last verified
- Jul 2022
- First submitted
- 12 Dec 2021
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gutt R, Dawson G, Cheuk AV, Fosmire H, Moghanaki D, Kelly M, Jolly S. Palliative Radiotherapy for the Management of Metastatic Cancer: Bone Metastases, Spinal Cord Compression, and Brain Metastases. Fed Pract. 2015 May;32(Suppl 4):12S-16S.
PubMed 30766118Nayak L, Lee EQ, Wen PY. Epidemiology of brain metastases. Curr Oncol Rep. 2012 Feb;14(1):48-54. doi: 10.1007/s11912-011-0203-y.
PubMed 22012633Achrol AS, Rennert RC, Anders C, Soffietti R, Ahluwalia MS, Nayak L, Peters S, Arvold ND, Harsh GR, Steeg PS, Chang SD. Brain metastases. Nat Rev Dis Primers. 2019 Jan 17;5(1):5. doi: 10.1038/s41572-018-0055-y.
PubMed 30655533Martinez P, Mak RH, Oxnard GR. Targeted Therapy as an Alternative to Whole-Brain Radiotherapy in EGFR-Mutant or ALK-Positive Non-Small-Cell Lung Cancer With Brain Metastases. JAMA Oncol. 2017 Sep 1;3(9):1274-1275. doi: 10.1001/jamaoncol.2017.1047.
PubMed 28520828Godfrey SE. Estrogen receptors. Am J Clin Pathol. 1989 May;91(5):629-30. doi: 10.1093/ajcp/91.5.629. No abstract available.
PubMed 2718965Greene-Schloesser D, Robbins ME, Peiffer AM, Shaw EG, Wheeler KT, Chan MD. Radiation-induced brain injury: A review. Front Oncol. 2012 Jul 19;2:73. doi: 10.3389/fonc.2012.00073. eCollection 2012.
PubMed 22833841Tsao MN, Xu W, Wong RK, Lloyd N, Laperriere N, Sahgal A, Rakovitch E, Chow E. Whole brain radiotherapy for the treatment of newly diagnosed multiple brain metastases. Cochrane Database Syst Rev. 2018 Jan 25;1(1):CD003869. doi: 10.1002/14651858.CD003869.pub4.
PubMed 29365347Soike MH, Hughes RT, Farris M, McTyre ER, Cramer CK, Bourland JD, Chan MD. Does Stereotactic Radiosurgery Have a Role in the Management of Patients Presenting With 4 or More Brain Metastases? Neurosurgery. 2019 Mar 1;84(3):558-566. doi: 10.1093/neuros/nyy216.
PubMed 29860451Sahgal A, Aoyama H, Kocher M, Neupane B, Collette S, Tago M, Shaw P, Beyene J, Chang EL. Phase 3 trials of stereotactic radiosurgery with or without whole-brain radiation therapy for 1 to 4 brain metastases: individual patient data meta-analysis. Int J Radiat Oncol Biol Phys. 2015 Mar 15;91(4):710-7. doi: 10.1016/j.ijrobp.2014.10.024.
PubMed 25752382Sahgal A, Ruschin M, Ma L, Verbakel W, Larson D, Brown PD. Stereotactic radiosurgery alone for multiple brain metastases? A review of clinical and technical issues. Neuro Oncol. 2017 Apr 1;19(suppl_2):ii2-ii15. doi: 10.1093/neuonc/nox001.
PubMed 28380635Brown PD, Jaeckle K, Ballman KV, Farace E, Cerhan JH, Anderson SK, Carrero XW, Barker FG 2nd, Deming R, Burri SH, Menard C, Chung C, Stieber VW, Pollock BE, Galanis E, Buckner JC, Asher AL. Effect of Radiosurgery Alone vs Radiosurgery With Whole Brain Radiation Therapy on Cognitive Function in Patients With 1 to 3 Brain Metastases: A Randomized Clinical Trial. JAMA. 2016 Jul 26;316(4):401-409. doi: 10.1001/jama.2016.9839.
PubMed 27458945Nabors LB, Ammirati M, Bierman PJ, Brem H, Butowski N, Chamberlain MC, DeAngelis LM, Fenstermaker RA, Friedman A, Gilbert MR, Hesser D, Holdhoff M, Junck L, Lawson R, Loeffler JS, Maor MH, Moots PL, Morrison T, Mrugala MM, Newton HB, Portnow J, Raizer JJ, Recht L, Shrieve DC, Sills AK Jr, Tran D, Tran N, Vrionis FD, Wen PY, McMillian N, Ho M; National Comprehensive Cancer Network. Central nervous system cancers. J Natl Compr Canc Netw. 2013 Sep 1;11(9):1114-51. doi: 10.6004/jnccn.2013.0132.
PubMed 24029126Sahgal A. Point/Counterpoint: Stereotactic radiosurgery without whole-brain radiation for patients with a limited number of brain metastases: the current standard of care? Neuro Oncol. 2015 Jul;17(7):916-8. doi: 10.1093/neuonc/nov087. No abstract available.
PubMed 26092877Sahgal A, Larson D, Knisely J. Stereotactic radiosurgery alone for brain metastases. Lancet Oncol. 2015 Mar;16(3):249-50. doi: 10.1016/S1470-2045(14)71106-4. No abstract available.
PubMed 25752547Mohammadi AM, Recinos PF, Barnett GH, Weil RJ, Vogelbaum MA, Chao ST, Suh JH, Marko NF, Elson P, Neyman G, Angelov L. Role of Gamma Knife surgery in patients with 5 or more brain metastases. J Neurosurg. 2012 Dec;117 Suppl:5-12. doi: 10.3171/2012.8.GKS12983.
PubMed 23205782
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05477316
- Acronym / sponsor ID
- 0930-20
- Conditions
- Brain Metastases, Posterior Fossa Lesion, Cerebral Lesion
- Keywords
- Brain Metastases, Posterior Fossa, Cerebellum, Cerebral Lesion, Cerebrum
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Jul 2022 (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.
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
Detailed description
This study includes patients with brain metastases, presenting with more than 5 cerebellar lesions and less than 10 cerebral lesions. This is a pilot study assessing the efficacy of a novel, combined treatment approach involving Intensity-modulated Radiation Therapy (IMRT)/ Volumetric Modulated Arc Therapy (VMAT), with or without integrated boost to metastases, administered to the posterior fossa, and Stereotactic Radiosurgery (SRS) administered to cerebral lesions. This is opposed to the current recommended treatment approach for such cases, being whole brain radiotherapy (WBRT). While an effective treatment with respect to lesion control, WBRT is not ideal as the total deliverable dose is limited to 30 Gy due to toxicity. In addition, this technique is responsible for major side effects, especially neurocognitive deterioration.
There are select cases of multiple brain metastases which are predominantly found in the posterior fossa. Rectal cancer is one such notorious example, however this type of spread is not limited to one region.
The investigators hypothesize that utilizing the novel combinational treatment approach of IMRT and SRS in cerebral and cerebellar brain metastases will improve long term brain control, maintain the patients' cognitive function and potentially improve overall survival, as the need for potent WBRT will become obsolete.
Patients with multiple brain metastases present in the cerebrum and cerebellum will be treated with SRS and IMRT respectively, simultaneously (within 3 weeks of one another). Brain MRI scans will be performed before commencement of the novel treatment approach, at two month after RT, and then every 3 months, or as indicated clinically, after treatment start. Concurrently at each MRI scan time point, patients will be assessed based on brain and whole-body metastatic progression by RECIST. Patients will also be assessed for central nervous system (CNS) - progression free survival (PFS) and body-PFS, cognitive function, quality of life and overall survival status via standardized follow-up tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Radiation: Radiation treatmentIntensity-modulated Radiation Therapy (IMRT)/VMAT with integrated boost to the cerebellum and metastases and Stereotactic Radiosurgery (SRS) to the cerebral metastases as a novel treatment combination for brain metastases |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Presence of multiple brain metastasis, predominantly in the posterior fossa: more than 5 metastases in the cerebellum, and less than 10 metastases in the cerebrum, visible on MRI, regardless of tumor origin.
- Provided written informed consent.
- Be male or female and at least 18 years of age on the day of signing informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- A minimum life expectancy of at least 3 months
Key exclusion criteria (9 listed)
- Prior treatment with Whole brain radiation (WBRT) (previous SRS is allowed for limited, up to 4 metastases, six month or more prior to the study treatment, and the index metastases should be all new)
- An investigational drug within five half-lives of the compound.
- Spinal cord compression unless asymptomatic and stable.
- Leptomeningeal disease.
- Moderate or severe symptomatic brain metastases defined as per Radiation therapy Oncology Group acute morbidity grade 3 to 4.
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 |
|---|---|---|
| Radiation treatmentRadiation treatment of IMRT to the cerebellum and SRS to the cerebrum | Radiation | Treatment |
Primary outcome
Brain control: Central Nervous System (CNS)- Progression Free Survival (PFS)
Time frame: 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.
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.
3 secondary outcomes
Cognitive function
Time frame: 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.
Quality of life (QOL)
Time frame: 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.
Overall survival (OS)
Time frame: Status will be checked at every visit and follow up, until the date of death from any cause, up to 10 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Background: PubMed 30766118Gutt R, Dawson G, Cheuk AV, Fosmire H, Moghanaki D, Kelly M, Jolly S. Palliative Radiotherapy for the Management of Metastatic Cancer: Bone Metastases, Spinal Cord Compression, and Brain Metastases. Fed Pract. 2015 May;32(Suppl 4):12S-16S.
- Background: PubMed 22012633Nayak L, Lee EQ, Wen PY. Epidemiology of brain metastases. Curr Oncol Rep. 2012 Feb;14(1):48-54. doi: 10.1007/s11912-011-0203-y.
- Background: PubMed 30655533Achrol AS, Rennert RC, Anders C, Soffietti R, Ahluwalia MS, Nayak L, Peters S, Arvold ND, Harsh GR, Steeg PS, Chang SD. Brain metastases. Nat Rev Dis Primers. 2019 Jan 17;5(1):5. doi: 10.1038/s41572-018-0055-y.
- Background: PubMed 28520828Martinez P, Mak RH, Oxnard GR. Targeted Therapy as an Alternative to Whole-Brain Radiotherapy in EGFR-Mutant or ALK-Positive Non-Small-Cell Lung Cancer With Brain Metastases. JAMA Oncol. 2017 Sep 1;3(9):1274-1275. doi: 10.1001/jamaoncol.2017.1047.
- Background: PubMed 2718965Godfrey SE. Estrogen receptors. Am J Clin Pathol. 1989 May;91(5):629-30. doi: 10.1093/ajcp/91.5.629. No abstract available.
- Background: PubMed 22833841Greene-Schloesser D, Robbins ME, Peiffer AM, Shaw EG, Wheeler KT, Chan MD. Radiation-induced brain injury: A review. Front Oncol. 2012 Jul 19;2:73. doi: 10.3389/fonc.2012.00073. eCollection 2012.
- Background: PubMed 29365347Tsao MN, Xu W, Wong RK, Lloyd N, Laperriere N, Sahgal A, Rakovitch E, Chow E. Whole brain radiotherapy for the treatment of newly diagnosed multiple brain metastases. Cochrane Database Syst Rev. 2018 Jan 25;1(1):CD003869. doi: 10.1002/14651858.CD003869.pub4.
- Background: PubMed 29860451Soike MH, Hughes RT, Farris M, McTyre ER, Cramer CK, Bourland JD, Chan MD. Does Stereotactic Radiosurgery Have a Role in the Management of Patients Presenting With 4 or More Brain Metastases? Neurosurgery. 2019 Mar 1;84(3):558-566. doi: 10.1093/neuros/nyy216.
- Background: PubMed 25752382Sahgal A, Aoyama H, Kocher M, Neupane B, Collette S, Tago M, Shaw P, Beyene J, Chang EL. Phase 3 trials of stereotactic radiosurgery with or without whole-brain radiation therapy for 1 to 4 brain metastases: individual patient data meta-analysis. Int J Radiat Oncol Biol Phys. 2015 Mar 15;91(4):710-7. doi: 10.1016/j.ijrobp.2014.10.024.
- Background: PubMed 28380635Sahgal A, Ruschin M, Ma L, Verbakel W, Larson D, Brown PD. Stereotactic radiosurgery alone for multiple brain metastases? A review of clinical and technical issues. Neuro Oncol. 2017 Apr 1;19(suppl_2):ii2-ii15. doi: 10.1093/neuonc/nox001.
- Background: PubMed 27458945Brown PD, Jaeckle K, Ballman KV, Farace E, Cerhan JH, Anderson SK, Carrero XW, Barker FG 2nd, Deming R, Burri SH, Menard C, Chung C, Stieber VW, Pollock BE, Galanis E, Buckner JC, Asher AL. Effect of Radiosurgery Alone vs Radiosurgery With Whole Brain Radiation Therapy on Cognitive Function in Patients With 1 to 3 Brain Metastases: A Randomized Clinical Trial. JAMA. 2016 Jul 26;316(4):401-409. doi: 10.1001/jama.2016.9839.
- Background: PubMed 24029126Nabors LB, Ammirati M, Bierman PJ, Brem H, Butowski N, Chamberlain MC, DeAngelis LM, Fenstermaker RA, Friedman A, Gilbert MR, Hesser D, Holdhoff M, Junck L, Lawson R, Loeffler JS, Maor MH, Moots PL, Morrison T, Mrugala MM, Newton HB, Portnow J, Raizer JJ, Recht L, Shrieve DC, Sills AK Jr, Tran D, Tran N, Vrionis FD, Wen PY, McMillian N, Ho M; National Comprehensive Cancer Network. Central nervous system cancers. J Natl Compr Canc Netw. 2013 Sep 1;11(9):1114-51. doi: 10.6004/jnccn.2013.0132.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation treatment in people with Brain Metastases and Posterior Fossa Lesion, run by Hadassah Medical Organization at 1 site in Israel.
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 11 inclusion and 9 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 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain control: Central Nervous System (CNS)- Progression Free Survival (PFS) (time frame: 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.). 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 NCT05477316, which also lists 21 linked publications.
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 28 Jul 2022.