Phase II single-arm non-inferiority clinical trial for oncological safety of hippocampus-sparing reduced-dose whole-brain radiotherapy after rituximab, methotrexate, procarbazine, vincristine chemotherapy in primary central nervous lymphoma

Seoul National University Hospital0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年8月19日

适应症

试验速览

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•Patient is 19 years of age or older at the time of diagnosis
•Patient has been diagnosed with B-cell non-Hodgkin's lymphoma in the central nervous system through a tissue examination of the brain or eye or through a pathological examination in the eye.
•Patient has received at least 4 cycles of induction chemotherapy that includes rituximab, methotrexate, procarbazine, and vincristine, with each cycle lasting 2 weeks.
•Patient is in complete remission (CR or CRu) or partial remission (PR) according to the recommendations of the International Primary CNS Lymphoma Collaborative Group (IPCG) after induction chemotherapy.
•Patient has an ECOG performance status of 0–2 (however, a performance status of 3 may be allowed if the cause is neurological deficit due to lymphoma).
•Patient has tumor lesions on both sides of the brain that are at least 10mm apart and show contrast enhancement on MRI.
•Patient has adequate hematologic function for receiving whole-brain radiotherapy (absolute neutrophil count =1,000/mm3, hemoglobin =7.0 g/dL, platelet count =50,000/mm3).
•Patient has given written informed consent after sufficient explanation and voluntarily agrees to participate in the study.

•? Patients with lymphoma metastasis confirmed in sites other than brain, eye, and cerebrospinal fluid at the time of initial diagnosis (confirmed by chest/abdominal/pelvic CT scan, bone scan, or cerebrospinal fluid examination)
•? In cases where tracking and observation through contrast-enhanced MRI is difficult (insertion of metal artificial objects, uncontrollable contrast-enhanced allergy, etc.)
•? Patients with positive HIV serology or other immunocompromised diseases requiring treatment
•? Pregnant or planned female patients (for male patients, they must agree to contraception during the study period)
•? Patients currently participating in a study using investigational drugs or medical devices
•? Systemically treated active infectious patients
•? Patients diagnosed with malignant tumors within the past 3 years excluding papillary thyroid cancer, basal cell skin cancer, and carcinomas of the breast and uterus
•? Patients who have previously received chemotherapy for lymphoma
•? Patients who have received radiotherapy to the nasopharynx.

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