Clinical Trials Logo

Clinical Trial Summary

Background. Primary central nervous system lymphoma (PCNSL) is an uncommon disease. Conventional treatment has consisted of either whole brain radiotherapy (WBRT) or methotrexate (MTX)-based combined modality therapy combining chemotherapy and cranial irradiation. The treatment principles at our institute have been quite consistent in the past, sticking to the treatment protocol reported by Memorial Sloan-Kettering Cancer Center in 1990s. No matter what the dosage of MTX is, it is well-established that the addition of chemotherapy to cranial RT significantly improved survival outcomes. However, it was found that delayed treatment-related cognitive sequelae emerged as a significant debilitating complication of combined modality treatment in patients with PCNSL, especially when effective treatment can achieve disease control and better survival rates. Furthermore, the specific contribution of the disease per se and various treatment modalities to cognitive impairment remains to be clarified because the neurotoxic potential of combined modality treatments is difficult to differentiate when each can result in cognitive dysfunctions respectively.

Treatment-related neurotoxicity could be demonstrated by virtue of several meaningful indicators, including neurobehavioral assessments, neuroimaging outcomes, and even measures of quality-of-life (QoL).

Methods. Therefore, this one-year individual research will be a prospective observational cohort study with a longitudinal assessment of neurobehavioral functions, neuroimaging, and quality of life for newly-diagnosed patients with primary CNS lymphoma at our institute. According to our cancer center, it is estimated that there would be around 25 cases of newly-diagnosed primary CNS lymphoma at our institute every year. By virtue of multidisciplinary management and teamwork consisting of neurosurgery, hematology, radiation oncology, neuroimaging expertise, and surgical pathology, investigators will attempt to recruit all potentially eligible patients with newly-diagnosed primary CNS lymphoma. Most importantly, the neuropsychologists will participate in our research project, in an effort to integrate the neurobehavioral outcomes into this prospective study. Accordingly, a battery of neuropsychological measures is used to evaluate neurobehavioral functions for the studied patients. The battery is composed of ten standardized neuropsychological tests, covering four domains sensitive to disease and treatment effects (executive function, attention, verbal memory, psychomotor speed), and QoL questionnaires.

Expected results. This prospective cohort study aims to explore and evaluate patients with PCNSL who are newly-diagnosed by using a standard battery of neurobehavioral functions plus neuroimaging studies. It is anticipated investigators will investigate and correlate neurotoxicity indicators in newly-diagnosed patients with PCNSL who are treated with cranial radiotherapy combined with or without MTX-based chemotherapy according to the multidisciplinary treatment guidelines implemented at a single institute.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02655744
Study type Observational
Source Chang Gung Memorial Hospital
Contact Chi-Cheng Chuang, M.D.
Phone +886-33281200
Email ccc2915@cgmh.org.tw
Status Recruiting
Phase
Start date November 2015
Completion date December 31, 2018

See also
  Status Clinical Trial Phase
Recruiting NCT02313389 - Maintenance Treatment Versus Observation in Elderly Patients With PCNS Lymphoma Phase 3
Recruiting NCT02836158 - Therapeutic Effects of R-IDARAM and Intrathecal Immunochemotherapy on Elderly Patients With PCNSL Phase 2/Phase 3
Enrolling by invitation NCT02657785 - Treatment of PCNSL With R-IDARAM and Intrathecal Immunochemotherapy Phase 2/Phase 3
Active, not recruiting NCT01421524 - Study of CC-122 to Evaluate the Safety, Tolerability, and Effectiveness for Patients With Advanced Solid Tumors, Non-Hodgkin's Lymphoma, or Multiple Myeloma Phase 1
Active, not recruiting NCT00863460 - Cranial Radiotherapy or Intensive Chemotherapy With Hematopoietic Stem Cell Rescue for Primary Central Nervous System Lymphoma in Young Patients Phase 2
Not yet recruiting NCT03495960 - Study on Tailored Treatment in Elderly Patients With Newly Diagnosed Primary Lymphoma of Central Nervous System Phase 2
Recruiting NCT03733327 - BUCYE Conditioning Regimen for PCNSL Undergoing Auto-HSCT Phase 2/Phase 3
Completed NCT02669511 - PQR309 in Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma Phase 2
Recruiting NCT00455286 - a Phase II Study in Primary Central Nervous System Lymphoma Phase 2
Completed NCT02301364 - Buparlisib (BKM120) In Patients With Recurrent/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Recurrent/Refractory Secondary Central Nervous System Lymphoma (SCNSL) Phase 2
Completed NCT00112593 - Fludarabine and Total-Body Irradiation Followed By Donor Stem Cell Transplant and Cyclosporine and Mycophenolate Mofetil in Treating HIV-Positive Patients With or Without Cancer N/A
Recruiting NCT02399189 - MT-R Followed by Autologous Stem Cells Transplantation in Newly-diagnosed Primary Central Nervous System Lymphoma Phase 2
Recruiting NCT02779101 - Study on Pembrolizumab for Recurrent Primary Central Nervous System Lymphoma (PCNSL) Phase 2
Recruiting NCT03582254 - Role of [18F]-FDG Brain PET in Newly Diagnosed Primary Cerebral Lymphoma, in Immunocompetent Patient Older Than 60 Years N/A
Terminated NCT02113007 - Study of High-Dose Rituximab With Temozolomide as Treatment for Primary Central Nervous System (CNS) Lymphoma Phase 2
Completed NCT00193973 - Idarubicin Based Combined Modality Therapy in Primary CNS Lymphoma Phase 2
Not yet recruiting NCT02983942 - Ketogenic Diet Adjunctive to HD-MTX Chemotherapy for Primary Central Nervous System Lymphoma Phase 1/Phase 2
Terminated NCT01944943 - Phase II Study of Vismodegib in Patients With Refractory or Relapsed B-cell Lymphoma or Chronic Lymphocytic Leukemia Phase 2
Withdrawn NCT00712062 - Study of Pemetrexed to Treat Recurrent or Progressive Primary Central Nervous System Lymphoma Phase 2
Withdrawn NCT03120000 - PQR309 in Phase 2 in Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma Phase 2