Follow-up on neurobehavioral outcomes in patients with primary CNS lymphoma treated with radiotherapy and chemotherapy
Prospective Neurobehavioral Outcomes Follow-up in Primary CNS Lymphoma Patients Treated With Cranial Radiotherapy Combined With or Without MTX-based Chemotherapy According to the Multidisciplinary Treatment Guidelines Implemented at a Single Institute
This study looks at how treatment for primary CNS lymphoma affects thinking and behavior in patients who received radiation and chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 84 Years |
| Sex | All |
| Sponsor | Chang Gung Memorial Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation, methotrexate |
| Locations | 1 site (Taoyuan) |
| Trial ID | NCT02655744 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the neurobehavioral outcomes in patients diagnosed with primary central nervous system lymphoma (PCNSL) who have undergone treatment with cranial radiotherapy, with or without methotrexate-based chemotherapy. The study will evaluate the cognitive effects and potential neurotoxicity associated with these treatment modalities, following a consistent treatment protocol established at Chang Gung Memorial Hospital. By analyzing the long-term cognitive sequelae in these patients, the study seeks to clarify the contributions of both the disease and the treatments to cognitive impairment.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with a confirmed diagnosis of primary CNS lymphoma who are undergoing standard treatment protocols involving cranial radiotherapy and chemotherapy.
Not a fit: Patients with a history of major psychiatric disease or prior cranial irradiation are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the cognitive effects of treatments for PCNSL, potentially leading to improved management strategies for patients.
How similar studies have performed: While there have been studies on the cognitive effects of cancer treatments, this specific approach focusing on PCNSL and its neurobehavioral outcomes is relatively novel.
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.