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Prospective Neurobehavioral Functions in Newly-diagnosed Patients With Primary CNS Lymphoma Treated With Hyperfractionated Conformal Whole-brain Radiation Therapy Plus Simultaneous Integrated Boost

Recruitingn/aAges 18 Years - 80 YearsAllChang Gung Memorial Hospital
NCT04006561 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Primary central nervous system lymphoma (PCNSL) is an uncommon disease. Conventional treatment has consisted of either whole-brain radiation therapy (WBRT) or methotrexate (MTX)-based combined modality therapy integrating chemotherapy with cranial irradiation in a sandwiched manner. No matter whether the dosage of MTX is high or conventional, combining chemotherapy with WBRT greatly improves intracranial tumor control and even survival outcomes. However, delayed treatment-related neurotoxicity and neurocognitive sequelae emerged as a significant debilitating complication in PCNSL patients, especially when effective combined chemoradiation can achieve disease control and long-term survival rates. Therefore, by delivering hyperfractionated conformal WBRT plus SIB, this prospective cohort study aims to accomplish both optimal intracranial control and minimal WBRT induced neurocognitive decl

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📋 Eligibility rules (as published)
Inclusion Criteria: * All patients must have a histopathologic diagnosis of non-Hodgkin's lymphoma (NHL) by brain biopsy * A typical MRI/CT scan for primary CNS lymphoma is defined as the presence of hypo, iso, or hyperintense parenchymal contrast-enhancing (usually homogeneously) mass lesion(s) * Patients must have a normal or negative pre-treatment systemic evaluation including: i. A bone marrow aspirate and biopsy ii. CT scans of the chest, abdomen and pelvis iii. Patients must have adequate bone marrow reserve * Patients must be HIV-1 negative * Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment Exclusion Criteria: * A past history of major psychiatric disease * Prior cranial irradiation for any reasons * Other active primary cancer with the exception of basal cell carcinoma of skin and cervical carcinoma in situ * Pre-existing immunodeficiency such as renal transplant recipient
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What it tests

  • A treatment protocol of combined chemoradiation delivered in the manner of hyperfractionated conformal whole-brain radiation therapy
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Where

1 site
Chang Gung Memorial Hospital
Taoyuan, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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