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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

Tracking Information
First Submitted Date December 9, 2015
First Posted Date January 14, 2016
Last Update Posted Date January 30, 2019
Study Start Date November 2015
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 12, 2016)
  • 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 Addition Test‐Revised
  • 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.
  • 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.
  • 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).
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02655744 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 12, 2016)
  • 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 Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
Official Title Not Provided
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population newly-diagnosed patients with primary CNS lymphoma
Condition Primary Central Nervous System Lymphoma
Intervention Radiation: Standard treatment protocol with combined chemoradiation
Study Groups/Cohorts newly-diagnosed patients with primary CNS lymphoma
Intervention: Radiation: Standard treatment protocol with combined chemoradiation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 12, 2016)
25
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 84 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT02655744
Other Study ID Numbers 102-5392B
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Chang Gung Memorial Hospital
Study Sponsor Chang Gung Memorial Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Chang Gung Memorial Hospital
Verification Date May 2018