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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

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ClinicalTrials.gov Identifier: NCT02655744
Recruitment Status : Recruiting
First Posted : January 14, 2016
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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 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.


Condition or disease Intervention/treatment
Primary Central Nervous System Lymphoma Radiation: Standard treatment protocol with combined chemoradiation

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : November 2015
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022


Group/Cohort Intervention/treatment
newly-diagnosed patients with primary CNS lymphoma Radiation: Standard treatment protocol with combined chemoradiation



Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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 Addition Test‐Revised


  5. The change in executive 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 :

    Modified Card Sorting Test.


  6. The change in verbal fluency 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 :

    Semantic association of verbal fluency.


  7. The change in Intelligence 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 :

    Wechsler Adult Intelligence Scale (WAIS‐III‐R).



Secondary Outcome Measures :
  1. 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. ]
  2. 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.


  3. 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.


  4. 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).


  5. 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).




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Ages Eligible for Study:   18 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
newly-diagnosed patients with primary CNS lymphoma
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02655744


Contacts
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Contact: Chi-Cheng Chuang, M.D. +886-33281200 ext 2412 ccc2915@cgmh.org.tw
Contact: Shinn-Yn Lin, M.D. +886-33281200 ext 7172 rt3126@gmail.com

Locations
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Taiwan
Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 333
Contact: Shinn-Yn Lin, M.D.    +886-33281200 ext 7172    rt3126@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital

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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02655744     History of Changes
Other Study ID Numbers: 102-5392B
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: May 2018
Keywords provided by Chang Gung Memorial Hospital:
Neurobehavioral Assessment
Radiotherapy (RT)
Chemotherapy
Neurotoxicity
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases