Mucosal Malignant Melanoma of the Head and Neck
Conditions
Interventions
None listed
Sponsors
Gunma University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with histologically proven mucosal malignant melanoma of the head and neck region. 2) Patients with N0M0 (TNM classification, 8th edition). 3) Patients with measurable lesions. 4) Patients who are scheduled to receive heavy particle radiotherapy. 5) Patients who are 16 years of age or older. 6) Patients whose Performance Status (PS) is 0-2. 7) Patients who have been informed of the name and condition of their disease and have the capacity to consent. (For minors, the consent of a legal guardian is required.)
Exclusion criteria
Exclusion criteria: 1) Patients with a history of radiation therapy to the area to be treated. 2) Patients with active and refractory infection at the irradiated site. 3) Patients with serious complications (uncontrolled diabetes mellitus, myocardial infarction requiring emergency treatment, unstable angina, uncontrolled arrhythmia, bleeding tendency due to untreated bleeding disorder, collagen disease requiring steroid administration, etc.) 4) Patients with active multiple cancers (simultaneous multiple cancers and iatrogenic multiple cancers with a disease-free interval of 5 years or less). However, lesions equivalent to intraepithelial or intramucosal carcinoma that are considered curable by local treatment are not included in the active overlapping cancers. 5) Other patients who are deemed medically, psychologically, or due to other factors to be inappropriate by the physician in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The overall survival rate will be evaluated between two groups, one with and the other without immune checkpoint inhibitors administered within the usual care after carbon ion radiotherapy. | — |
Countries
Japan
Contacts
Public ContactAtsushi Musha
Gunma University Heavy Ion Medical Center
Outcome results
None listed