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Comparative evaluation of the efficiency of a new protocol of the primitive LYMPHOME of the central nervous system ( LPSNC) to the old subject, associating Methotrexate and Temozolomide with regard to a standard protocol associating Methotrexate, Procarbazine, Vincristine and Cytarabine.

Methotrexate and temozolomide

Methotrexate , procarbazine ,vincristine ,cytarabine

Antonio OMURO, MD,PhD

Antonio OMURO, MD,

The purpose of this study is to evaluate two types of chemotherapy for primary central nervous system lymphoma in the elderly (age older than 60) :

* Methotrexate, procarbazine, vincristine and cytarabine
* Methotrexate and temozolomide

The aim of the study is to evaluate efficacy and toxicity associated with both protocols in this population, without radiotherapy.

Patients will be randomized to receive one of the two regimens in one of the participating centers. Neuropsychological evaluation will be performed in all patients. Patients will be followed with serial MRIs.

Methotrexate and Temozolomide Versus Methotrexate, Procarbazine, Vincristine and Cytarabine

Multicenter Randomized Phase II Study of Methotrexate (MTX) and Temozolomide Versus MTX, Procarbazine, Vincristine and Cytarabine for Primary CNS Lymphoma (PCNSL) in the Elderly

French Innovative Leukemia Organisation

Assistance Publique - Hôpitaux de Paris

Symptoms and General Pathology

Neoplasm Metastasis

Glioblastoma

Confirmation of the difference between FLAIR contrast enhancement and T1 contrast enhancement patterns--\>PACS monitor shows the maximum dimension of FLAIR and T1 contrast enhancement by two neurology radiologists on FLAIR and T1 contrast enhancement images. In addition, the maximum diameter of the T2 high-signal lesion around the tumor is obtained using FLAIR images before contrast in the same plane. (Dt2)

Usefulness of Gadovist-enhanced FLAIR imaging in differentiation between a glioblastoma and solitary brain metastasis

Ryoo In Seon, dotorate

Polyplastic glioblastoma and metastatic brain cancer are the most common malignant brain tumors in adults. The primary diagnostic test for tumors in the brain shows magnetic resonance imaging or similar imaging findings (especially single metastatic brain cancer) that make it difficult to distinguish between these two diseases. In addition, due to the specificity of the tissue called the brain, biopsy is not easy and sometimes biopsy is difficult, so non-invasive discrimination is often important, and it is important how much prediction is made before the biopsy. To solve this problem, various advanced magnetic resonance imaging techniques have been studied, but they are all tests that need to be additionally conducted on ordinary magnetic resonance images, and there are many subjective factors, so complex data and statistical processing methods, and many cannot be easily tested. In addition, in all of these tests, accuracy is still reported at around 60%. Therefore, if contrast-enhanced FLAIR images can be obtained along with contrast-enhanced T1 images performed during conventional magnetic resonance imaging tests to help differentiate between two diseases, it will greatly help diagnose and treat brain tumor patients and facilitate clinical application.

Polyplastic glioblastoma and metastatic brain tumors are the most common brain tumors in adults. Polyplastic glioblastoma is the most common tumor among malignant primary brain tumors, and metastatic brain tumors are the most common brain tumors in adults. In the diagnosis of brain tumors, magnetic resonance imaging is the most basic and primary imaging technique to date. However, in the case of a single metastatic brain tumor, the tumor shape, signal intensity, contrast enhancement pattern, and peripheral signal intensity appear so similar that they are hardly distinguished from polymorphic glioblastoma in conventional magnetic resonance images. However, it is very important to distinguish between the two diseases because the above two diseases have completely different characteristics in clinical aspects, surgical method decisions, treatment decisions, and prognosis. Obtaining histological results will be the ultimate answer, but due to the nature of tissue called the brain, non-invasive tests are preferred, and sometimes patients (e.g., cardiovascular disease) or lesions themselves cannot handle surgery are in a very important part of the brain, so it depends on imaging techniques. In addition, the distinction between the two diseases through imaging is important in that it is important to predict in advance even if biopsy is performed through surgery. Therefore, various advanced magnetic resonance imaging techniques such as diffusion-enhanced imaging (DWI), perfusion imaging (perfusion), and spectroscopic imaging (MR spectroscopy) have been attempted to better differentiate the two diseases through imaging tests. However, these images are additional imaging tests that need to be obtained after obtaining conventional magnetic resonance images and are usually accompanied by complex and various statistical analyses due to many subjective elements. In addition, there are tests that are difficult to conduct other than large hospitals with a certain size or larger. Nevertheless, the accuracy of the discrimination between the two diseases to date is around 60%. In addition, such tests are often difficult to perform in most hospitals, except for large hospitals with a certain size or larger. Therefore, if the two diseases can be better identified in conventional magnetic resonance imaging, it will be of great help to patient care clinically and it is expected that actual clinical application will be easier. Contrast-enhanced T1 highlighted images are always performed in conventional magnetic resonance images, and after that, one more FLAIR image is obtained to see if contrast-enhanced FLAIR images are helpful in differentiating the two diseases.

For a single malignant mass in the brain, conventional T1 highlighted contrast enhancement findings and histological results (glioblastoma/metastatic brain cancer) were compared and analyzed, followed by diagnosing a single brain mass (Df/Dt1, Dt2/Dt1, Dt2/Df ratio) and histological results.

Usefulness of Gadovist-enhanced FLAIR Imaging

Usefulness of Gadovist-enhanced FLAIR Imaging in Differentiation Between a Glioblastoma and Solitary Brain Metastasis: Single Center Prospective Study

Two 3.0 Tesla MR machines (MAGNETOM Trio A Tim and MAGNETOM Prisma; Siemens, Erlangen, Germany) were used in this study. The protocol consisted of axial FLAIR (TR/TE/TI=9,000/100/2,500 milliseconds, with slice thickness of 2 mm) and axial spin-echo T1-weighted image (TR/TE=675/8.9 milliseconds, with slice thickness of 2 mm). After both pre-enhancement images are acquired, CE-T1WI and CE-FLAIR sequences were obtained 5 and 10 minutes after administering gadolinium-based contrast agents, respectively. Gadobutrol (Gadovist™, 0.1 millimol per kilogram of body weight, Schering AG, Berlin, Germany) was used as the contrast agent, via automated injector (Spectris MR; Medrad Europe, Maastricht, Netherlands). Subtraction images for both CE-FLAIR and CE-T1WI sequences were also obtained. Detailed protocol image sequence parameter is provided in shown in Online Resource 2.

Ryoo, In Seon

Associate Professor of Radiology

Nervous System Diseases

Substance Related Disorders

Neurotoxicity Syndromes

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.

A treatment protocol of combined chemoradiation delivered in the manner of hyperfractionated conformal whole-brain radiation therapy

Chi-Cheng Chuang, M.D.

Shinn-Yn Lin, M.D.

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.

Prospective Neurobehavioral Functions in Newly-diagnosed Patients With Primary CNS Lymphoma Treated With Hyperfractionated Conformal Whole-brain Radiation Therapy Plus Simultaneous Integrated Boost

Prospective Neurobehavioral Evaluation in Newly-diagnosed Patients With Primary CNS Lymphoma Treated With Hyperfractionated Conformal Whole-brain Radiation Therapy Plus Simultaneous Integrated Boost

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 Word Sequence Learning Test is an assessment of verbal memory. To evaluate auditory memory of verbal information without context.

The Modified Card Sorting Test is an assessment of executive function, related to conceptual formation and mental shifting.

The Trail Making Test is an assessment of speed and flexibility, used to measure the ability of visual attention and task switching.

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.

Neurocognitive assessment including: Paced Auditory Serial Addition Test-Revised

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.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Methotrexate and Temozolomide Versus Methotrexate, Procarbazine, Vincristine and Cytarabine	NCT00503594	Lymphoma	Methotrexate an... Methotrexate , ...	60 Years -	Assistance Publique - Hôpitaux de Paris
Methotrexate and Temozolomide Versus Methotrexate, Procarbazine, Vincristine and Cytarabine	NCT00503594	Lymphoma	Methotrexate an... Methotrexate , ...	60 Years -	Assistance Publique - Hôpitaux de Paris
Usefulness of Gadovist-enhanced FLAIR Imaging	NCT05293990	Malignant Tumor... Brain Lymphoma CNS Lymphoma	Usefulness of G...	19 Years -	Korea University Guro Hospital
Usefulness of Gadovist-enhanced FLAIR Imaging	NCT05293990	Malignant Tumor... Brain Lymphoma CNS Lymphoma	Usefulness of G...	19 Years -	Korea University Guro Hospital
Prospective Neurobehavioral Functions in Newly-diagnosed Patients With Primary CNS Lymphoma Treated With Hyperfractionated Conformal Whole-brain Radiation Therapy Plus Simultaneous Integrated Boost	NCT04006561	Primary CNS Lym... Brain Lymphoma	A treatment pro...	18 Years - 80 Years	Chang Gung Memorial Hospital

Spots Global Cancer Trial Database for brain lymphoma