A Study to Assess the Efficacy of Cerebellar IMRT Combined With Cerebral SRS in Patients With Bra… (NCT05477316) | Clinical Trial Compass
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A Study to Assess the Efficacy of Cerebellar IMRT Combined With Cerebral SRS in Patients With Brain Metastases
Israel37 participantsStarted 2021-02-11
Plain-language 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
Who can participate
Age range18 Years – 99 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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:
✓. Willing to use adequate contraceptive measures until 6 weeks after the final dose of study treatment
✓. Not breast feeding
Exclusion criteria
✕. 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.
What they're measuring
1
Brain control: Central Nervous System (CNS)- Progression Free Survival (PFS)
Timeframe: 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.
✕. 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.