Boron Neutron Capture Therapy Using CICS-1 and SPM-011 for Malignant Melanoma and Angiosarcoma (NCT04293289) | Clinical Trial Compass
CompletedNot Applicable
Boron Neutron Capture Therapy Using CICS-1 and SPM-011 for Malignant Melanoma and Angiosarcoma
Japan10 participantsStarted 2019-11-19
Plain-language summary
Among skin malignancies, patients with malignant melanoma or angiosarcoma are treated with BNCT using CICS-1 and SPM-011 (borofalan (10B)). Through this trial, safety and appropriate treatment dose will be determined.
Who can participate
Age range
20 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients with primary malignant melanoma or angiosarcoma diagnosed histopathologically
. Patients with superficial skin lesions whose maximum diameter of the target lesion is 15 cm or less
. Patients with lesions that are lying 6 cm or less from the skin surface to the deepest part of the tumor
. Patients with lesions in the head, neck, chest, or extremities
. Patients who do not have apparent abnormal hematological and biochemical values in the latest screening test within 28 days of registration
Exclusion criteria
. Patients with obvious disseminated lesions
. Patients who have undergone previous treatment of radiation therapy exceeding 75 Gy for the target lesion.
. Patients with active lesions / active multiple cancers in addition to the target lesion
. Patients with infections that require systemic treatment.
. Patients with active implantable medical devices
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The frequency of DLT(Dose Limiting Toxicity) occurence (Safety)