Clinical Trial: 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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title:

Brief 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

Detailed Summary:
Sponsor: Chang Gung Memorial Hospital

Current Primary Outcome:

  • The change in neurocognitive functions from baseline up to 4 months after completing all courses of chemoradiation. [ Time Frame: one week before the WBRT course, up to 4 months after completing all courses of chemoradiation ]

    Neurocognitive assessment including :

    Trail Making Test.

  • The change in memory functions from baseline up to 4 months after completing all courses of chemoradiation. [ Time Frame: one week before the WBRT course, up to 4 months after completing all courses of chemoradiation ]

    Neurocognitive assessment including :

    Word Sequence Learning Test.

  • The change in general cognitive functions from baseline up to 4 months after completing all courses of chemoradiation. [ Time Frame: one week before the WBRT course, up to 4 months after completing all courses of chemoradiation ]

    Neurocognitive assessment including :

    Mini Mental Status Examination.

  • The change in attention functions from baseline up to 4 months after completing all courses of chemoradiation. [ Time Frame: one week before the WBRT course, up to 4 months after completing all courses of chemoradiation ]

    Neurocognitive assessment including :

    Paced Auditory Serial Ad

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • The time from the date of recruitment to that of intracranial progression/failure noted on brain MRI [ Time Frame: Baseline before the WBRT course; 2 months after completing all courses of chemoradiation, and then 4 months later. ]
    • Depression Inventory questionnaires. [ Time Frame: Baseline before the WBRT course; one month after completing the WBRT course; 2 months after completing all courses of chemoradiation, and then 4 months later. ]

      Questionnaires include:

      Beck Depression Inventory.

    • Anxiety Inventory questionnaires. [ Time Frame: Baseline before the WBRT course; one month after completing the WBRT course; 2 months after completing all courses of chemoradiation, and then 4 months later. ]

      Questionnaires include:

      Beck Anxiety Inventory.

    • Self- Evaluation questionnaires. [ Time Frame: Baseline before the WBRT course; one month after completing the WBRT course; 2 months after completing all courses of chemoradiation, and then 4 months later. ]

      Questionnaires include:

      National Taiwan University Irritability Scale Self- Evaluation (NTUIS‐Self).

    • Family Evaluation questionnaires. [ Time Frame: Baseline before the WBRT course; one month after completing the WBRT course; 2 months after completing all courses of chemoradiation, and then 4 months later. ]

      Questionnaires include:

      National Taiwan University Irritability Scale‐Family Evaluation (NTUIS‐Family).



    Original Secondary Outcome: Same as current

    Information By: Chang Gung Memorial Hospital

    Dates:
    Date Received: December 9, 2015
    Date Started: November 2015
    Date Completion: December 31, 2018
    Last Updated: April 17, 2017
    Last Verified: April 2017