Evaluating neurobehavioral functions in newly diagnosed primary CNS lymphoma patients receiving advanced radiation therapy
Prospective Neurobehavioral Evaluation in Newly-diagnosed Patients With Primary CNS Lymphoma Treated With Hyperfractionated Conformal Whole-brain Radiation Therapy Plus Simultaneous Integrated Boost
Chang Gung Memorial Hospital · NCT04006561
This study is testing a new radiation therapy for people newly diagnosed with primary CNS lymphoma to see if it can control the tumor while also helping to protect their thinking and memory skills.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Chang Gung Memorial Hospital (other) |
| Drugs / interventions | chemotherapy, radiation, methotrexate |
| Locations | 1 site (Taoyuan) |
| Trial ID | NCT04006561 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients newly diagnosed with primary central nervous system lymphoma (PCNSL) who will receive hyperfractionated conformal whole-brain radiation therapy combined with a simultaneous integrated boost. The aim is to achieve effective tumor control while minimizing neurocognitive decline, a common side effect of traditional treatments. Patients will undergo a thorough neurobehavioral and neurocognitive assessment to evaluate the impact of this treatment approach. The study seeks to provide insights into the balance between effective cancer treatment and the preservation of cognitive functions.
Who should consider this trial
Good fit: Ideal candidates include individuals with a confirmed diagnosis of non-Hodgkin's lymphoma in the brain who meet specific health criteria.
Not a fit: Patients with a history of major psychiatric disease or prior cranial irradiation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and better quality of life for patients by reducing neurocognitive side effects associated with treatment.
How similar studies have performed: While there have been studies on conventional treatments for PCNSL, this specific approach of hyperfractionated conformal WBRT with SIB is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Taoyuan
- Chang Gung Memorial Hospital — Taoyuan, Taiwan (RECRUITING)
Study contacts
- Study coordinator: Chi-Cheng Chuang, M.D.
- Email: ccc2915@cgmh.org.tw
- Phone: +886-33281200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Primary CNS Lymphoma, Brain Lymphoma, Neurobehavioral Assessment, Neurocognitive Function, Whole-Brain Radiation Therapy, Simultaneous Integrated Boost, Hyperfractionation, Radiotherapy