Behaviors and Mental Disorders

All Conditions

Neoplasms

Nervous System Diseases

Rare Diseases

Anxiety Disorders

Glioblastoma

Glioma

Brain Neoplasms

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Patients receive standard of care verbal and written education materials. Patients also receive a customized video which includes a description of each of their tumor, functional areas of the brain affected, and possible symptoms from the tumor and radiation treatment based on the neuro-imaging features. Patients and their caregivers watch the video together or separately over 1.5-3 minutes before the end of the first week of radiation treatment. Within 2 weeks after watching the NIRS video, patients complete an optional survey over 5-10 minutes.

Patients receive standard of care verbal and written education materials.

Receive standard of care verbal and written education materials

Educational Intervention

Questionnaire Administration

Survey Administration

Video

Caroline Chung

This trial studies whether a customized video intervention can help to reduce anxiety in brain cancer patients undergoing radiation treatment and their caregivers. A customized neuro-imaging referenced symptom video that describes symptoms and side effects specific to the patients' tumor may result in an early and sustained reduction in anxiety and distress during and after radiation treatment, thereby improving quality of life.

PRIMARY OBJECTIVE:

I. To determine if provision of a neuro-imaging referenced symptom (NIRS) video intervention for patients starting radiotherapy for newly diagnosed primary brain tumors reduces patient anxiety during radiation compared to standard of care information.

SECONDARY OBJECTIVES:

I. To determine if provision of a NIRS video intervention for patients starting radiotherapy for newly diagnosed primary brain tumors reduces caregiver anxiety during radiation compared to standard of care information.

II. To determine if any changes in patient or caregiver anxiety early during radiation are sustained after the completion of radiation.

III. To investigate whether changes in anxiety are associated with changes in quality of life and distress in patients.

IV. To investigate whether patients perceive the NIRS intervention to have been helpful in understanding possible tumor and treatment symptoms.

OUTLINE: Patients and their caregivers are randomized to 1 of 2 arms.

ARM I (NIRS VIDEO): Patients receive standard of care verbal and written education materials. Patients also receive a customized NIRS video which includes a description of each their tumor, functional areas of the brain affected, and possible symptoms from the tumor and radiation treatment based on the neuro-imaging features. Patients and their caregivers watch the video together or separately over 1.5-3 minutes before the end of the first week of radiation treatment. Within 2 weeks after watching the NIRS video, patients complete an optional survey over 5-10 minutes.

ARM II (STANDARD OF CARE EDUCATION): Patients receive standard of care verbal and written education materials.

After completion of radiation treatment, patients are followed up at 1 month.

Customized Neuro-Imaging Referenced Symptom Video for the Reduction of Patient and Caregiver Anxiety Around Radiation Treatment for Brain Tumors

Novel Intervention to Reduce Patient and Caregiver Anxiety Around Radiation Treatment for Brain Tumors With a Customized Neuro-Imaging Referenced Symptom Video

Using linear mixed models (LMMs) to evaluate the change in STAI between and within groups. The correlation structure over time will be selected using the Bayesian information criterion. Will calculate correlations between reduction in anxiety and improvement in quality of life (Functional Assessment of Cancer Therapy Scale-Brain \[FACT- Br\]) and distress (Distress Thermometer). Analysis will focus on the between-group comparison of the changes of the patient S-Anxiety subscale score of the STAI from baseline to 2 weeks and from baseline to 6 weeks in to RT. All tests conducted will use a two-sided 0.05 significance level, without adjusting for multiple testing.

Analysis will focus on the between-group comparison of the changes of the caregiver S-Anxiety subscale score of the STAI from baseline to 2 weeks and from baseline to 6 weeks in to RT. All tests conducted will use a two-sided .05 significance level, without adjusting for multiple testing.

Analysis will be performed by testing for the effects of time, in particular, differences between the average of weeks 2 and 6 during RT and 1 month after RT. All tests conducted will use a two-sided .05 significance level, without adjusting for multiple testing.

Evaluates the impact between distress and overall quality of life in patients. LMMs will be used to assess the correlations between change in anxiety and change in quality of life, etc., without including time as an independent variable, yet with within-subject correlations still accounted for. For each fixed time point, simple correlations will also be calculated. All tests conducted will use a two-sided .05 significance level, without adjusting for multiple testing.

Evaluates whether neuro-imaging referenced symptom intervention was subjectively helpful in understanding their tumor and treatment symptoms and alleviating their anxiety. Relevant summary statistics will be computed. All tests conducted will use a two-sided .05 significance level, without adjusting for multiple testing.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

250 mg, twice daily, continuous oral administration

DS-1001b

Clinical Study Leader

This Phase 2 study is conducted to assess the efficacy and safety of DS-1001b in patients with chemotherapy- and radiotherapy-naive IDH1 mutated WHO grade II glioma.

A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma

A Phase II Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-naive IDH1 Mutated WHO Grade II Glioma

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Daiichi Sankyo Co., Ltd.

Symptoms and General Pathology

Recurrence

Disease Attributes

Other Dietary Supplements

All Drugs and Chemicals

Pyruvate

Patients undergo MRI and MRSI scans over 1 hour at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care. Participants enrolled in cohort 1 may later enroll in cohort 2 of study once eligibility has been reviewed and approved by neuro-oncologist

Patients undergo MRI scan at baseline. Patients then receive hyperpolarized carbon C 13 pyruvate IV over less than 1 minute and undergo MRSI scan at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care.

Hyperpolarized Carbon C 13 Pyruvate

Magnetic Resonance Imaging

Magnetic Resonance Spectroscopic Imaging

Wendy Ma

Susan M. Chang, MD

Susan M Chang, MD

This trial studies how well serial magnetic resonance (MR) imaging and MR spectroscopic imaging work in characterizing lower grade glioma. Diagnostic procedures, such as MR imaging and MR spectroscopic imaging, may detect serial changes in lower grade glioma. This study may help researchers learn more about practical ways of evaluating and standardizing treatment in patients with brain tumors.

PRIMARY OBJECTIVES:

I. To assess the safety and feasibility of hyperpolarized 13C MR metabolic imaging as a new and unique tool for making an early assessment of progression and evaluation of response to therapy in patients with lower grade glioma II. To determine whether changes in levels of hyperpolarized 13C pyruvate, lactate and bicarbonate may provide early evidence of tumor progression in patients with lower grade glioma who are being followed with surveillance scans.

III. To determine whether patients with lower grade glioma who are receiving treatment exhibit a reduction in levels of hyperpolarized 13C lactate/pyruvate at follow-up compared to their baseline scan.

OUTLINE: Patients will be enrolled into Cohort 2. Participants previously enrolled in Cohort 1 may enroll in Cohort 2 of study upon re-review of eligibility.

COHORT 1 (CLOSED TO ENROLLMENT): Patients undergo MR imaging (MRI) and MR spectroscopic imaging (MRSI) scans over 1 hour at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care.

COHORT 2: Patients undergo MRI scan at baseline. Patients then receive hyperpolarized carbon C 13 pyruvate intravenously (IV) over less than 1 minute and undergo MRSI scan at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care.

Serial MR Imaging and MR Spectroscopic Imaging for the Characterization of Lower Grade Glioma

Metabolic Imaging of Patients With Lower Grade Glioma Using Hyperpolarized 13C Pyruvate

Safety evaluation for endpoint will include monitoring for the occurrence of treatment-emergent adverse events (AEs). Reported toxicities will be graded using the National Cancer Institute (NCI) Common Terminology (Toxicity) Criteria for Adverse Events (CTCAE) version 4.0. All available safety data will be used and will be analyzed using descriptive statistics.

The peak lactate/pyruvate in tumor and normal appearing brain tissue will be reported.

The peak bicarbonate/pyruvate in tumor and normal appearing brain tissue will be reported.

The change in peak lactate/pyruvate between scans will be reported.

The change in peak bicarbonate/pyruvate between scans will be reported.

GE Healthcare

Sigma-Aldrich

Phillips-Medisize

Susan Chang

Principal Investigator

Oligodendroglioma

Anaplastic Astrocytoma

Anaplastic Oligodendroglioma

Diffuse Astrocytoma

Oligoastrocytoma

Anaplastic Oligoastrocytoma

Antineoplastic Agents

Temozolomide

Antineoplastic Agents, Alkylating

Alkylating Agents

Patients receive temozolomide PO daily and radiation therapy over 5 days a week (weekdays only) for 6 weeks. Beginning 28 days after the last dose of radiation therapy, patients receive temozolomide PO for 12 months in the absence of disease progression or unacceptable toxicity.

Quality-of-Life Assessment

Radiation Therapy

Debra N Yeboa

Debra N. Yeboa

This phase II trial studies how well temozolomide and radiation therapy work in treating patients with IDH wildtype historically lower grade gliomas or non-histological molecular glioblastomas. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The goal of this clinical research study is to compare receiving new radiation therapy doses and volumes to the prior standard treatment for patients with historically grade II or grade III IDH wild-type gliomas, which may now be referred to as IDH wildtype molecular glioblastomas at some institutions. Receiving temozolomide in combination with radiation therapy may also help to control the disease.

PRIMARY OBJECTIVE:

I. To determine the progression free survival (PFS) based on Response Assessment in Neuro-Oncology (RANO) imaging criteria from start of treatment with concurrent chemoradiation (CRT) and adjuvant temozolomide (TMZ).

SECONDARY OBJECTIVE:

I. To determine the 3-year overall survival (OS) of isocitrate dehydrogenase (IDH) wild-type grade II and grade III gliomas with dose escalation radiation with concurrent chemoradiation therapy.

EXPLORATORY OBJECTIVES:

I. To assess local control patterns (site of 1st progression). II. To evaluate neuro-cognitive function by the Neurocognitive Clinical Trial Battery (CTB).

III. To evaluate the treatment related symptoms, overall symptom impact, and disease related factor groupings utilizing the M.D. Anderson Symptom Inventory Brain Tumor (MDASI-BT).

IV. To assess the quality of life.

OUTLINE:

Patients receive temozolomide orally (PO) daily and radiation therapy over 5 days a week (weekdays only) for 6 weeks. Beginning 28 days after the last dose of radiation therapy, patients receive temozolomide PO for 12 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1, 3, 5, 7, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months.

Chemotherapy and Radiation Therapy for the Treatment of IDH Wildtype Gliomas or Non-histological (Molecular) Glioblastomas

Phase II Trial of Treatment Intensification for IDH Wildtype, Non-Histological Glioblastoma, Gliomas (IDH Wildtype Lower Grade Glioma Treatment Intensification)

Will be summarized with frequency and proportion.

Assessed by the Neurocognitive Clinical Trial Battery, and summarized with descriptive summary statistics.

Assessed by the M.D. Anderson Symptom Inventory Brain Tumor (MDASI-BT), and summarized using standard descriptive statistics such as mean, standard deviation, median and range. Wilcoxon rank-sum test or Kruskal Wallis test will be used to examine the difference on MDASI-BT between or among patients' characteristics groups.

Assessed by linear analog self-assessment (LASA) scale, will be summarized using standard descriptive statistics such as mean, standard deviation, median and range. Wilcoxon rank-sum test or Kruskal-Wallis test will be used to examine the difference on LASA scale between or among patients' characteristics groups.

Tumor progression is defined by the Response Assessment in Neuro-Oncology glioma criteria. PFS time will be estimated using the Kaplan-Meier method. The 1-year PFS rate will be estimated along with a 95% confidence interval. Patient or tumor characteristics (ex. grade, age, etc) will be compared within the single study cohort. Cox regression models will be applied to assess the effect of covariates of interest on PFS.

The 3-year OS rate is defined as the proportion of participants that are alive at 3-year after the start of treatment, which will be estimated along a 95% confidence interval. OS time will be estimated using the Kaplan-Meier method. Patient or tumor characteristics (ex. grade, age, etc) will be compared within the single study cohort. Cox regression models will be applied to assess the effect of covariates of interest on OS.

Patients undergo intensity-modulated (IM)-stereotactic radiotherapy (SRT) daily over 6 weeks.

Intensity-Modulated Radiation Therapy

Quality-of-Life

Wenyin Shi, MD

David Andrews, MD

This phase II trial studies how well intensity-modulated stereotactic radiation therapy works in treating patients with grade II-IV glioma. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue.

PRIMARY OBJECTIVES:

I. To determine the effect of intensity-modulated (IM)-stereotactic radiotherapy (SRT) on the incidence of wound infection (requiring oral/intravenous \[IV\] antibiotics or surgery), or wound dehiscence.

SECONDARY OBJECTIVES:

I. To determine the effect of IM-SRT on the incidence of titanium implants as palpable cranial defects due to scalp thinning.

II. To determine the effect of IM-SRT on the incidence of hair loss and recovery rate.

III. To determine the effect on quality of life (QoL) using European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L).

TERTIARY OBJECTIVES:

I. To determine if treatment of Intensity-modulated stereotactic radiotherapy (IM-SRT) in patients with newly diagnosed grade II-IV gliomas can decrease the loss of scalp thickness in the coronal plane in T-1W magnetic resonance (MR) images.

Intensity-Modulated Stereotactic Radiation Therapy in Treating Patients With Grade II-IV Glioma

Intensity-Modulated Stereotactic Radiotherapy as an Upfront Scalp-Sparing Intervention for the Treatment of Newly Diagnosed Grade II-IV Gliomas

Will assess the IM-SRT on scalp thickness as determined by magnetic resonance imaging evaluations of scalp thickness in the coronal plane before conformal radiation therapy (XRT), at 9 months, and 18 months after XRT in the study group compared to time-matched historical controls of patients. Mixed effects linear regression will be used to jointly model scalp thickness measurements at pre-treatment, 9 months, and 18 months. Potential confounding factors (chemotherapy, smoking history, diabetes) will also be included in the model. The residual variance covariance matrix will be assumed to have a compound-symmetric structure to account for the correlation among repeated measurements. Linear contrasts will be used to compare the change from pre-treatment to 9 months between IM-SRT and conformal therapy patients and to compare the change from pre treatment to 18 months between IM-SRT and conformal therapy patients.

Will assess the impact of intensity-modulated stereotactic radiotherapy (IM-SRT) on the incidence of wound infection, or wound dehiscence.

Will the impact of IM-SRT on the incidence of titanium implants as palpable cranial defects due to scalp thinning. Rates of titanium implant discomfort will be summarized by cohort with exact 95% confidence intervals. Within-cohort changes will be estimated using linear contrasts of model parameters.

Will assess the impact of IM-SRT on the incidence of hair loss. Will be summarized by cohort with exact 95% confidence intervals. Within-cohort changes will be estimated using linear contrasts of model parameters.

Will assess the impact of IM-SRT on the incidence of recovery rate. Will be summarized by cohort with exact 95% confidence intervals. Within-cohort changes will be estimated using linear contrasts of model parameters.

Will assess the impact on quality of life using European Quality of Life Five Dimension Five Level Scale Questionnaire. Will be modeled using mixed effects linear regression. Within-cohort changes will be estimated using linear contrasts of model parameters.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Customized Neuro-Imaging Referenced Symptom Video for the Reduction of Patient and Caregiver Anxiety Around Radiation Treatment for Brain Tumors	NCT04479696	Glioblastoma WHO Grade II Gl... WHO Grade III G...	Educational Int... Questionnaire A... Survey Administ... Video	18 Years -	M.D. Anderson Cancer Center
A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma	NCT04458272	WHO Grade II Gl...	DS-1001b	20 Years -	Daiichi Sankyo
Serial MR Imaging and MR Spectroscopic Imaging for the Characterization of Lower Grade Glioma	NCT04540107	Recurrent World... Recurrent WHO G... WHO Grade II Gl... WHO Grade III G...	Hyperpolarized ... Magnetic Resona... Magnetic Resona...	18 Years -	University of California, San Francisco
Chemotherapy and Radiation Therapy for the Treatment of IDH Wildtype Gliomas or Non-histological (Molecular) Glioblastomas	NCT04623931	Anaplastic Astr... Anaplastic Olig... Anaplastic Olig... Diffuse Astrocy... Glioblastoma Oligoastrocytom... Oligodendroglio... WHO Grade II Gl... WHO Grade III G...	Quality-of-Life... Questionnaire A... Radiation Thera... Temozolomide	18 Years -	M.D. Anderson Cancer Center
A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma	NCT04458272	WHO Grade II Gl...	DS-1001b	20 Years -	Daiichi Sankyo
Customized Neuro-Imaging Referenced Symptom Video for the Reduction of Patient and Caregiver Anxiety Around Radiation Treatment for Brain Tumors	NCT04479696	Glioblastoma WHO Grade II Gl... WHO Grade III G...	Educational Int... Questionnaire A... Survey Administ... Video	18 Years -	M.D. Anderson Cancer Center
Intensity-Modulated Stereotactic Radiation Therapy in Treating Patients With Grade II-IV Glioma	NCT03251027	Glioblastoma WHO Grade II Gl... WHO Grade III G...	Intensity-Modul... Quality-of-Life	18 Years -	Thomas Jefferson University

Spots Global Cancer Trial Database for who grade ii glioma