Primary Central Nervous System LymphomaNCT02655744
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
An observational study of Primary Central Nervous System Lymphoma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Primary Central Nervous System Lymphoma
- What is being tested?
- Standard treatment protocol with combined chemoradiation
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2015to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: newly-diagnosed patients with primary CNS lymphoma
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan, 333
Shinn-Yn Lin, M.D., +886-33281200 ext. 7172, rt3126@gmail.com
About this study
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).
Read more
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.
- Conditions
- Primary Central Nervous System Lymphoma
- Being tested
- Standard treatment protocol with combined chemoradiation
- Keywords
- Neurobehavioral Assessment, Radiotherapy (RT), Chemotherapy, Neurotoxicity
- Medical subject headings
- Neurotoxicity Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard treatment protocol with combined chemoradiationRadiation
| Study group | Role | What they receive |
|---|---|---|
| newly-diagnosed patients with primary CNS lymphoma | Not described Receives: Radiation: Standard treatment protocol with combined chemoradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in neurocognitive functions from baseline up to 4 months after completing all courses of chemoradiation.
Neurocognitive assessment including :
Trail Making Test.
Measured: one week before the WBRT course, up to 4 months after completing all courses of chemoradiation
The change in memory functions from baseline up to 4 months after completing all courses of chemoradiation.
Neurocognitive assessment including :
Word Sequence Learning Test.
Measured: one week before the WBRT course, up to 4 months after completing all courses of chemoradiation
The change in general cognitive functions from baseline up to 4 months after completing all courses of chemoradiation.
Neurocognitive assessment including :
Mini Mental Status Examination.
Measured: one week before the WBRT course, up to 4 months after completing all courses of chemoradiation
The change in attention functions from baseline up to 4 months after completing all courses of chemoradiation.
Neurocognitive assessment including :
Paced Auditory Serial Addition Test-Revised
Measured: one week before the WBRT course, up to 4 months after completing all courses of chemoradiation
The change in executive functions from baseline up to 4 months after completing all courses of chemoradiation.
Neurocognitive assessment including :
Modified Card Sorting Test.
Measured: one week before the WBRT course, up to 4 months after completing all courses of chemoradiation
The change in verbal fluency from baseline up to 4 months after completing all courses of chemoradiation.
Neurocognitive assessment including :
Semantic association of verbal fluency.
Measured: one week before the WBRT course, up to 4 months after completing all courses of chemoradiation
The change in Intelligence from baseline up to 4 months after completing all courses of chemoradiation.
Neurocognitive assessment including :
Wechsler Adult Intelligence Scale (WAIS-III-R).
Measured: one week before the WBRT course, up to 4 months after completing all courses of chemoradiation
Secondary outcomes (5)
The time from the date of recruitment to that of intracranial progression/failure noted on brain MRI
Measured: Baseline before the WBRT course; 2 months after completing all courses of chemoradiation, and then 4 months later.
Depression Inventory questionnaires.
Questionnaires include:
Beck Depression Inventory.
Measured: 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.
Anxiety Inventory questionnaires.
Questionnaires include:
Beck Anxiety Inventory.
Measured: 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.
Self- Evaluation questionnaires.
Questionnaires include:
National Taiwan University Irritability Scale Self- Evaluation (NTUIS-Self).
Measured: 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.
Family Evaluation questionnaires.
Questionnaires include:
National Taiwan University Irritability Scale-Family Evaluation (NTUIS-Family).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study start1 Nov 2015
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Central Nervous System LymphomaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655744
- Sponsor's protocol ID
- 102-5392B
- Status last verified
- Apr 2023
- First submitted
- 9 Dec 2015
- Last updated
- 1 May 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02655744
- Acronym / sponsor ID
- 102-5392B
- Conditions
- Primary Central Nervous System Lymphoma
- Keywords
- Neurobehavioral Assessment, Radiotherapy (RT), Chemotherapy, Neurotoxicity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| newly-diagnosed patients with primary CNS lymphoma | – | Radiation: Standard treatment protocol with combined chemoradiation |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- newly-diagnosed patients with primary CNS lymphoma
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard treatment protocol with combined chemoradiation | Radiation | newly-diagnosed patients with primary CNS lymphoma |
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 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).
5 secondary outcomes
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Central Nervous System Lymphoma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chi-Cheng Chuang, M.D. (+886-33281200 ext. 2412, ccc2915@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023.