Whole Brain Irradiation in Primary Central Nervous System (CNS) Lymphoma (PCNSL)
Central Nervous System Lymphoma
About this trial
This is an interventional treatment trial for Central Nervous System Lymphoma focused on measuring primary central nervous system lymphoma
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically/immunocytologically confirmed primary non-Hodgkin's lymphoma of the CNS. A central reference pathological report will be made on inclusion into the study (Prof. Dr. Pietsch, Reference Center for Brain Tumors of the German Society for Neuropathology and Neuroanatomy, Institute of Neuropathology of the Bonn University Hospital). Histological diagnosis is usually performed by preferential stereotactic biopsy of suspicious lesions in the brain or spinal cord. The diagnosis from cerebrospinal fluid (CSF) requires the detection of malignant lymphocytes according to cytological and immunocytological criteria. There should be no more than 2 weeks between establishing the diagnosis and inclusion in the study. The availability of the reference pathological report is not absolutely necessary for inclusion in the study and beginning therapy. Aged > 18 years Life expectancy of at least 2 months Adequate bone marrow reserve with a peripheral granulocyte count of > 1,500/µl and thrombocyte count of > 100,000/µl; bilirubin in the normal range; GOT of < three times the upper normal limit and adequate renal function with a creatinine clearance of > 50 ml/min and serum creatinine in the normal range. Written informed consent In women of child-bearing age, pregnancy is excluded, effective contraception is necessary, and women should not be breast feeding. Exclusion Criteria: Manifestation of lymphoma outside of the CNS Severe diseases in other organs which would make performing intensive chemotherapy impossible; Karnofsky index > 50% due to previous diseases other than PCNSL. Karnofsky > 30 will be accepted only due to the PCNSL. Active infection HIV positivity Previous treatment of PCNSL other than with corticosteroids, antiepileptics or diuretics Previous radiotherapy of the brain Concomitant or previous malignant diseases in the last 5 years except for an adequately treated basal cell carcinoma or cervical carcinoma in situ Immunosuppression, concomitant immunosuppressive therapy, or organ transplantation Ongoing chemotherapy for another disease
Sites / Locations
- Charite Campus Benjamin Franklin
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
1
2
1 chemotherapy with radiotherapy
chemotherapy without radiotherapy