An interventional study of Hypofractionated Whole-Brain Radiotherapy in the Treatment of Disseminated Cutaneous and Mucosal Melanoma Patients With Multiple Brain Metastases and Whole-Brain Radiotherapy in the Treatment of Disseminated Cutaneous and Mucosal Melanoma Patients With Multiple Brain Metastases in Melanoma Brain Metastases, sponsored by National Medical Research Radiological Centre of the Ministry of Health of Russia. Completed at 1 site in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by National Medical Research Radiological Centre of the Ministry of Health of Russia · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to compare an extreme hypofractionation regimen (6.5 Gy per fraction, total 26 Gy) with standard fractionation (3 Gy per fraction, total 30 Gy) for WBRT in patients with multiple melanoma brain metastases. The main questions it aims to answer are:
Does hypofractionated WBRT increases OS? How effective is the hypofractionation regimen in local control compared to the standart fractionation? Will the toxicity increase? Will the quality of life increase in an experimental group?
2,440 studies on the registry are indexed under Brain Neoplasms; 540 are open to participants now.
This study's enrollment of 50 is above the median of 40 across 1,831 interventional studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →National Medical Research Radiological Centre of the Ministry of Health of Russia is the lead sponsor of 11 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard fractionation: 3 Gy daily (5 times per week) to a total of 30 Gy (10 fractions, 12-14 days)
Radiation: Whole-Brain Radiotherapy in the Treatment of Disseminated Cutaneous and Mucosal Melanoma Patients With Multiple Brain Metastases
Hypofractionation: 6.5 Gy per fraction every other day (3 times per week) to a total of 26 Gy (4 fractions, 8 days)
Radiation: Hypofractionated Whole-Brain Radiotherapy in the Treatment of Disseminated Cutaneous and Mucosal Melanoma Patients With Multiple Brain Metastases
Hypofractionated Whole-Brain Radiotherapy in the Treatment of Disseminated Cutaneous and Mucosal Melanoma Patients With Multiple Brain Metastases.
Whole-Brain Radiotherapy in the Treatment of Disseminated Cutaneous and Mucosal Melanoma Patients With Multiple Brain Metastases
Tolerability of therapy with assesment of early and late radiation toxicity
Acute CNS radiation toxicity grade (grade 0-4; % of patients per grade; median grade, 95% CI), RTOG Acute Radiation Morbidity Scoring Criteria
Time frame: 3 years
Tolerability of therapy with assesment of early and late radiation toxicity
Acute skin radiation toxicity grade (grade 0-4; % of patients per grade; median grade, 95% CI), RTOG Acute Radiation Morbidity Scoring Criteria
Time frame: 3 years
Tolerability of therapy with assesment of early and late radiation toxicity
Acute ear radiation toxicity grade (grade 0-4; % of patients per grade; median grade, 95% CI), RTOG Acute Radiation Morbidity Scoring Criteria
Time frame: 3 years
Tolerability of therapy with assesment of early and late radiation toxicity
Late CNS radiation toxicity grade (grade 0-4; % of patients per grade; median grade, 95% CI), RTOG/EORTC Late Radiation Morbidity Scoring Schema
Time frame: 3 years
Tolerability of therapy with assesment of early and late radiation toxicity
Late mucosal radiation toxicity grade (grade 0-4; % of patients per grade; median grade, 95% CI), RTOG/EORTC Late Radiation Morbidity Scoring Schema
Time frame: 3 years
Tolerability of therapy with assesment of early and late radiation toxicity
Incidence and severity of dizziness (grade 0-4; % of patients per grade; median grade, 95% CI), Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: 3 years
Tolerability of therapy with assesment of early and late radiation toxicity
Incidence and severity of headache (grade 0-4; % of patients per grade; median grade, 95% CI), Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: 3 years
Tolerability of therapy with assesment of early and late radiation toxicity
Incidence and severity of insomnia (grade 0-4; % of patients per grade; median grade, 95% CI), Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: 3 years
Tolerability of therapy with assesment of early and late radiation toxicity
Incidence and severity of tremor (grade 0-4; % of patients per grade; median grade, 95% CI), Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: 3 years
Tolerability of therapy with assesment of early and late radiation toxicity
Incidence and severity of peripheral motor neuropathy (grade 0-4; % of patients per grade; median grade, 95% CI), Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: 3 years
Tolerability of therapy with assesment of early and late radiation toxicity
Incidence and severity of peripheral sensory neuropathy (grade 0-4; % of patients per grade; median grade, 95% CI), Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: 3 years
Tolerability of therapy with assesment of early and late radiation toxicity
Incidence and severity of depression (grade 0-4; % of patients per grade; median grade, 95% CI), Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: 3 years
Tolerability of therapy with assesment of early and late radiation toxicity
Incidence and severity of dry eye (grade 0-4; % of patients per grade; median grade, 95% CI), Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: 3 years
Tolerability of therapy with assesment of early and late radiation toxicity
Incidence and severity of hearing impairment (grade 0-4; % of patients per grade; median grade, 95% CI), Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: 3 years
Tolerability of therapy with assesment of early and late radiation toxicity
Incidence and severity of alopecia (grade 0-4; % of patients per grade; median grade, 95% CI), Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: 3 years
Tolerability of therapy with assesment of early and late radiation toxicity
Incidence and severity of skin erythema (grade 0-4; % of patients per grade; median grade, 95% CI), Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: 3 years
Tolerability of therapy with assesment of early and late radiation toxicity
Incidence and severity of memory impairment (grade 0-4; % of patients per grade; median grade, 95% CI), Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: 3 years
Tolerability of therapy with assesment of early and late radiation toxicity
Incidence and severity of concentration impairment (grade 0-4; % of patients per grade; median grade, 95% CI), Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: 3 years
Tolerability of therapy with assesment of early and late radiation toxicity
Incidence and severity of cognitive impairment (grade 0-4; % of patients per grade; median grade, 95% CI), Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: 3 years
Overall survival
Overall survival (OS) from radiotherapy initiation (months; median, 95% CI), Kaplan-Meier survival analysis
Time frame: 3 years
Local control
Local control rate (% of patients; complete response, near-complete response, partial response, positive stabilization, negative stabilization, progression), MRI-based volumetric response assessment (≥90% volume reduction = near-complete; ≥30% but \<90% = partial; \<30% reduction = stabilization; \>20% increase = progression)
Time frame: 3 years
Local control
Change in number of brain metastases (count difference before vs. after treatment; median, p-value), paired comparison of contrast-enhanced brain MRI data
Time frame: 3 years
Local control
Change in total intracranial metastatic volume (cm³ difference before vs. after treatment; median, mean ± SD, p-value), paired comparison of contrast-enhanced brain MRI data with tumor contouring in planning system
Time frame: 3 years
Cause of death
Cause of death (% of patients; intracranial - progression, hemorrhage into metastasis, spinal cord involvement; extracranial - disseminated disease, pulmonary hemorrhage, gastrointestinal hemorrhage), medical records review and death certificates
Time frame: 3 years
General somatic status
Karnofsky Performance Status score (points; median, 95% CI; % of patients by score: 40, 50, 60, 70, 80, 90), Karnofsky Performance Scale
Time frame: 3 years
General somatic status
ECOG Performance Status score (points; median, 95% CI; % of patients by grade: 0, 1, 2, 3, 4), ECOG performance status scale
Time frame: 3 years
Prognosis status
GPA score (points; median, 95% CI; % of patients by score: 0, 0.5, 1, 1.5, 2, 2.5, 3), Graded Prognostic Assessment (GPA) scale
Time frame: 3 years
Prognosis status
RPA class (class 1/2/3; % of patients), Recursive Partitioning Analysis (RPA) classification
Time frame: 3 years
Neurological status
NANO score (points; median, 95% CI; % of patients by score: 0-16), Neurologic Assessment in Neuro-Oncology (NANO) scale
Time frame: 3 years
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — anonymized patient data
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Access criteria: contact e-mail: maslov.egor.d@gmail.com
Ran from Jul 2022 to primary completion in Apr 2026, 45 months.
Of 306 non-industry interventional studies with no phase under Brain Neoplasms, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 125. This study's 45 months is below that.
Counting every sponsor, half of 317 studies reached it within 64 months; a quarter within 35 and three quarters within 125.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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National Medical Research Radiological Centre of the Ministry of Health of Russia