Primary CNS LymphomaNCT04006561
Prospective Neurobehavioral Functions in Newly-diagnosed Patients With Primary CNS Lymphoma Treated With Hyperfractionated Conformal Whole-brain Radiation Therapy Plus Simultaneous Integrated Boost
An observational study of Primary CNS Lymphoma and Brain Lymphoma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Primary central nervous system lymphoma (PCNSL) is an uncommon disease. Conventional treatment has consisted of either whole-brain radiation therapy (WBRT) or methotrexate (MTX)-based combined modality therapy integrating chemotherapy with cranial irradiation in a sandwiched manner. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary CNS Lymphoma, Brain Lymphoma
- What is being tested?
- A treatment protocol of combined chemoradiation delivered in the manner of hyperfractionated conformal whole-brain radiation therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 36 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2019to 18 Feb 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 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. Contact the study team or a site near you to ask about taking part.
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
Official title: Prospective Neurobehavioral Evaluation in Newly-diagnosed Patients With Primary CNS Lymphoma Treated With Hyperfractionated Conformal Whole-brain Radiation Therapy Plus Simultaneous Integrated Boost
Primary central nervous system lymphoma (PCNSL) is an uncommon disease. Conventional treatment has consisted of either whole-brain radiation therapy (WBRT) or methotrexate (MTX)-based combined modality therapy integrating chemotherapy with cranial irradiation in a sandwiched manner. No matter whether the dosage of MTX is high or conventional, combining chemotherapy with WBRT greatly improves intracranial tumor control and even survival outcomes. However, delayed treatment-related neurotoxicity and neurocognitive sequelae emerged as a significant debilitating complication in PCNSL patients, especially when effective combined chemoradiation can achieve disease control and long-term survival rates. Therefore, by delivering hyperfractionated conformal WBRT plus SIB, this prospective cohort study aims to accomplish both optimal intracranial control and minimal WBRT induced neurocognitive decline. Additionally, by administering objective multi-domain neurobehavioral/neurocognitive assessments, the change in neurocognitive functions (NCFs) before and after the course of hyperfractionated conformal WBRT will be investigated and analyzed.
According to the treatment guidelines for treating newly-diagnosed PCNSL patients, combined chemoradiation in which the WBRT course is sandwiched between initial courses of MTX and the later courses of chemotherapy with Ara-C is the treatment of mainstay at our institute. Employing the technique of a conformal CT treatment planning, the WBRT course is delivered in the manner of hyperfractionation with a reduced cumulative dose of 3600 cGy in 30 fractions during 3-4 weeks, administered twice daily in 1.2 Gy - fractions with at least 6 hours between fractions. By virtue of multidisciplinary management and teamwork including neurosurgery, hematology, radiation oncology, and neuroimaging expertise, it is attempted to recruit all potentially eligible patients with newly-diagnosed PCNSL. Most importantly, a professional neuropsychologist participates in this research project to integrate neurobehavioral outcomes into the prospective study. Accordingly, a battery of neuropsychological measures is used to evaluate predetermined NCFs for the studied patients. The test battery is composed of six standardized neuropsychological tests, covering four domains sensitive to disease and treatment effects (executive function, attention, verbal memory, information processing). The primary outcome measure is the change in patients' capability of information processing indicated by the Paced Auditory Serial Addition Test-Revised (PASAT-R), from the baseline before receiving the WBRT course to the follow-up after undergoing the entire courses of combined chemoradiation.
This prospective cohort study aims to thoroughly examine newly diagnosed PCNSL patients by using a standard battery of neurobehavioral/neurocognitive functions. Additionally, a better intracranial disease control is expected since the WBRT course relies on a highly conformal treatment planning integrated with the individualized arrangement of simultaneous integrated boost (SIB) to escalate the focal dose irradiating the originally involved site(s). Moreover, WBRT-related neurocognitive sequelae might be significantly less likely to occur because the WBRT course is delivered in the fashion of hyperfractionation, indicating a significantly lower dose per fraction and a reduced cumulative dose. Furthermore, it is anticipated the investigators will analyze which neurobehavioral domain would predict the treatment-related neurocognitive impacts to the largest extent in newly diagnosed PCNSL patients treated with cranial RT combined with or without MTX based chemotherapy according to the multidisciplinary treatment guidelines implemented at a single institute.
- Conditions
- Primary CNS Lymphoma, Brain Lymphoma
- Being tested
- A treatment protocol of combined chemoradiation delivered in the manner of hyperfractionated conformal whole-brain radiation therapy
- Keywords
- Primary CNS Lymphoma, Neurobehavioral Assessment, Neurocognitive Function (NCF), Whole-Brain Radiation Therapy (WBRT), Simultaneous Integrated Boost (SIB), Hyperfractionation, Radiotherapy, 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.
A treatment protocol of combined chemoradiation delivered in the manner of hyperfractionated conformal whole-brain radiation therapyRadiation
Each freshly-diagnosed patient with primary CNS lymphoma will be treated with combined chemoradiation in a sandwiched way, in which 2 cycles of induction chemotherapy with intravenous methotrexate (MTX in a conventional dose of 1g/m2) and intrathecal MTX are followed by a complete course of hyperfractionated WBRT and then high-dose cytarabine for 2 cycles.
| Study group | Role | What they receive |
|---|---|---|
| newly-diagnosed patients with primary CNS lymphoma | Not described Receives: Radiation: A treatment protocol of combined chemoradiation delivered in the manner of hyperfractionated conformal whole-brain radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the change in patients' capability of information processing, as determined by the assessment (the Paced Auditory Serial Addition Test-Revised) from baseline up to 30 months after completing all courses of chemoradiation.
The Paced Auditory Serial Addition Test-Revised is an assessment of information processing, used to assess the capacity and speed of information processing, as well as sustained and divided attention.
Measured: one week before the WBRT course, up to 30 months after completing all courses of chemoradiation
The primary endpoint is delayed recall, as determined by the change/decline in verbal memory (Word Sequence Learning Test) from baseline up to 30 months after completing all courses of chemoradiation.
The Word Sequence Learning Test is an assessment of verbal memory. To evaluate auditory memory of verbal information without context.
Measured: one week before the WBRT course, up to 30 months after completing all courses of chemoradiation
The primary endpoint is the change of executive function, as determined by three different domains assessments from baseline up to 30 months after completing all courses of chemoradiation.
The Modified Card Sorting Test is an assessment of executive function, related to conceptual formation and mental shifting.
Measured: one week before the WBRT course, up to 30 months after completing all courses of chemoradiation
The primary endpoint is the change of executive function, as determined by three different domains assessments from baseline up to 30 months after completing all courses of chemoradiation.
The Trail Making Test is an assessment of speed and flexibility, used to measure the ability of visual attention and task switching.
Measured: one week before the WBRT course, up to 30 months after completing all courses of chemoradiation
The primary endpoint is the change of executive function, as determined by three different domains assessments from baseline up to 30 months after completing all courses of chemoradiation.
The Semantic Association of Verbal Fluency Test is an assessment of verbal fluency, related to frontal and temporal cortex.
A measure of the ability of phonemic and semantic variants.
Measured: one week before the WBRT course, up to 30 months after completing all courses of chemoradiation
The change in attention functions from baseline up to 30 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 30 months after completing all courses of chemoradiation
Secondary outcomes (4)
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 follow up to 30 months
Depression Inventory questionnaires.
Questionnaires include: Beck Depression Inventory (BDI). The Beck Depression Inventory is a 21-question multiple-choice self-report inventory, used psychometric tests for measuring the severity of depression.
The BDI contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs used differ from the original:
0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; 29-63: severe depression.
Measured: Baseline before the WBRT course; one month after completing the WBRT course; 2 months after completing all courses of chemoradiation, and follow up to 30 months
Anxiety Inventory questionnaires.
Questionnaires include: Beck Anxiety Inventory (BAI). The Beck Anxiety Inventory (BAI) is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in children and adults.
The BAI contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms. The standardized cutoffs are:
0-7: minimal anxiety; 8-15: mild anxiety; 16-25: moderate anxiety; 26-63: severe anxiety.
Measured: Baseline before the WBRT course; one month after completing the WBRT course; 2 months after completing all courses of chemoradiation, and follow up to 30 months
Self & family Evaluation questionnaires.
Questionnaires include: National Taiwan University Irritability Scale Self Evaluation(NTUIS-Self), National Taiwan University Irritability Scale-Family Evaluation (NTUIS-Family).
The National Taiwan University Irritability Scale (NTUIS) is a self-reported scale with validated and reliable psychometric properties, to specifically evaluate irritability.
The NTUIS required patients to examine their irritability before and after disease.
The NTUIS is a 6-point Likert scale with 18 items. Each item was rated 1 (totally non-matched to patient's conditions) to 6 (totally matched to patient's conditions) with descriptions anchoring each matching level. Since "excessive emotional (e.g. anger and annoyance) and behavioural (e.g. verbal aggression) responses to stimuli" were used as the operational definition of irritability, the items considering anger, verbal aggression and annoyance were selected.
Measured: Baseline before the WBRT course; one month after completing the WBRT course; 2 months after completing all courses of chemoradiation, and follow up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start1 Mar 2019
- Primary completion18 Feb 2029 (estimated)
- Study completion18 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary CNS 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
- 36 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
- NCT04006561
- Sponsor's protocol ID
- 1812140031
- Status last verified
- Mar 2023
- First submitted
- 18 Jun 2019
- Last updated
- 1 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 Evaluation in Newly-diagnosed Patients With Primary CNS Lymphoma Treated With Hyperfractionated Conformal Whole-brain Radiation Therapy Plus Simultaneous Integrated Boost
- ClinicalTrials.gov ID
- NCT04006561
- Acronym / sponsor ID
- 1812140031
- Conditions
- Primary CNS Lymphoma, Brain Lymphoma
- Keywords
- Primary CNS Lymphoma, Neurobehavioral Assessment, Neurocognitive Function (NCF), Whole-Brain Radiation Therapy (WBRT), Simultaneous Integrated Boost (SIB), Hyperfractionation, Radiotherapy, Chemotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 18 Feb 2029 (estimated)
- Study completion
- 18 Feb 2029 (estimated)
- First posted
- 5 Jul 2019 (actual)
- 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.
Primary central nervous system lymphoma (PCNSL) is an uncommon disease. Conventional treatment has consisted of either whole-brain radiation therapy (WBRT) or methotrexate (MTX)-based combined modality therapy integrating chemotherapy with cranial irradiation in a sandwiched manner. No matter whether the dosage of MTX is high or conventional, combining chemotherapy with WBRT greatly improves intracranial tumor control and even survival outcomes. However, delayed treatment-related neurotoxicity and neurocognitive sequelae emerged as a significant debilitating complication in PCNSL patients, especially when effective combined chemoradiation can achieve disease control and long-term survival rates. Therefore, by delivering hyperfractionated conformal WBRT plus SIB, this prospective cohort study aims to accomplish both optimal intracranial control and minimal WBRT induced neurocognitive decline. Additionally, by administering objective multi-domain neurobehavioral/neurocognitive assessments, the change in neurocognitive functions (NCFs) before and after the course of hyperfractionated conformal WBRT will be investigated and analyzed.
According to the treatment guidelines for treating newly-diagnosed PCNSL patients, combined chemoradiation in which the WBRT course is sandwiched between initial courses of MTX and the later courses of chemotherapy with Ara-C is the treatment of mainstay at our institute. Employing the technique of a conformal CT treatment planning, the WBRT course is delivered in the manner of hyperfractionation with a reduced cumulative dose of 3600 cGy in 30 fractions during 3-4 weeks, administered twice daily in 1.2 Gy - fractions with at least 6 hours between fractions. By virtue of multidisciplinary management and teamwork including neurosurgery, hematology, radiation oncology, and neuroimaging expertise, it is attempted to recruit all potentially eligible patients with newly-diagnosed PCNSL. Most importantly, a professional neuropsychologist participates in this research project to integrate neurobehavioral outcomes into the prospective study. Accordingly, a battery of neuropsychological measures is used to evaluate predetermined NCFs for the studied patients. The test battery is composed of six standardized neuropsychological tests, covering four domains sensitive to disease and treatment effects (executive function, attention, verbal memory, information processing). The primary outcome measure is the change in patients' capability of information processing indicated by the Paced Auditory Serial Addition Test-Revised (PASAT-R), from the baseline before receiving the WBRT course to the follow-up after undergoing the entire courses of combined chemoradiation.
This prospective cohort study aims to thoroughly examine newly diagnosed PCNSL patients by using a standard battery of neurobehavioral/neurocognitive functions. Additionally, a better intracranial disease control is expected since the WBRT course relies on a highly conformal treatment planning integrated with the individualized arrangement of simultaneous integrated boost (SIB) to escalate the focal dose irradiating the originally involved site(s). Moreover, WBRT-related neurocognitive sequelae might be significantly less likely to occur because the WBRT course is delivered in the fashion of hyperfractionation, indicating a significantly lower dose per fraction and a reduced cumulative dose. Furthermore, it is anticipated the investigators will analyze which neurobehavioral domain would predict the treatment-related neurocognitive impacts to the largest extent in newly diagnosed PCNSL patients treated with cranial RT 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: A treatment protocol of combined chemoradiation delivered in the manner of hyperfractionated conformal whole-brain radiation therapy |
Who may qualify
- Ages
- 18 to 80 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 |
|---|---|---|
| A treatment protocol of combined chemoradiation delivered in the manner of hyperfractionated conformal whole-brain radiation therapyEach freshly-diagnosed patient with primary CNS lymphoma will be treated with combined chemoradiation in a sandwiched way, in which 2 cycles of induction chemotherapy with intravenous methotrexate (MTX in a conventional dose of 1g/m2) and intrathecal MTX are followed by a complete course of hyperfractionated WBRT and then high-dose cytarabine for 2 cycles. | Radiation | newly-diagnosed patients with primary CNS lymphoma |
Primary outcome
The primary endpoint is the change in patients' capability of information processing, as determined by the assessment (the Paced Auditory Serial Addition Test-Revised) from baseline up to 30 months after completing all courses of chemoradiation.
Time frame: one week before the WBRT course, up to 30 months after completing all courses of chemoradiation
The Paced Auditory Serial Addition Test-Revised is an assessment of information processing, used to assess the capacity and speed of information processing, as well as sustained and divided attention.
The primary endpoint is delayed recall, as determined by the change/decline in verbal memory (Word Sequence Learning Test) from baseline up to 30 months after completing all courses of chemoradiation.
Time frame: one week before the WBRT course, up to 30 months after completing all courses of chemoradiation
The Word Sequence Learning Test is an assessment of verbal memory. To evaluate auditory memory of verbal information without context.
The primary endpoint is the change of executive function, as determined by three different domains assessments from baseline up to 30 months after completing all courses of chemoradiation.
Time frame: one week before the WBRT course, up to 30 months after completing all courses of chemoradiation
The Modified Card Sorting Test is an assessment of executive function, related to conceptual formation and mental shifting.
The primary endpoint is the change of executive function, as determined by three different domains assessments from baseline up to 30 months after completing all courses of chemoradiation.
Time frame: one week before the WBRT course, up to 30 months after completing all courses of chemoradiation
The Trail Making Test is an assessment of speed and flexibility, used to measure the ability of visual attention and task switching.
The primary endpoint is the change of executive function, as determined by three different domains assessments from baseline up to 30 months after completing all courses of chemoradiation.
Time frame: one week before the WBRT course, up to 30 months after completing all courses of chemoradiation
The Semantic Association of Verbal Fluency Test is an assessment of verbal fluency, related to frontal and temporal cortex. A measure of the ability of phonemic and semantic variants.
The change in attention functions from baseline up to 30 months after completing all courses of chemoradiation.
Time frame: one week before the WBRT course, up to 30 months after completing all courses of chemoradiation
Neurocognitive assessment including: Paced Auditory Serial Addition Test-Revised
4 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 follow up to 30 months
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 follow up to 30 months
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 follow up to 30 months
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 follow up to 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
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.
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 CNS Lymphoma and Brain 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: looking for participants now, 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?
This study is still under way. Results are not available in the source record yet.
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 primary endpoint is the change in patients' capability of information processing, as determined by the assessment (the Paced Auditory Serial Addition Test-Revised) from baseline up to 30 months after completing all courses of chemoradiation. (time frame: one week before the WBRT course, up to 30 months after completing all courses of chemoradiation). The study lists 6 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.