Neoplasms

Symptoms and General Pathology

All Conditions

Nervous System Diseases

Behaviors and Mental Disorders

Neoplasm Metastasis

Brain Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Quality of Life

Image-Guided Hypofractionated Stereotactic Radiation Therapy (IGRT) of the resection cavity

Stereotactic Radiosurgery of the resection cavity (SRS)

IGRT

Gianfranco A Pesce, MD

Stereotactic radiosurgery or hypofractionated radiotherapy of the resection cavity after metastasectomy in cancer patients with brain metastases

Patients with limited number of brain metastases from solid tumors are at high risk of local recurrence after surgical removal of the tumor mass. The standard Whole-brain radiotherapy (WBRT) demonstrated to reduce the risk of recurrence without improving survival. At the same time WBRT have substantial acute and late toxicity. Preliminary experiences with Stereotactic radiosurgery or hypofractionated radiotherapy of the resection cavity indicate promising local control and good tolerance. This attitude was only partially explored in prospective trials. In this research patients with limited number of brain metastases and controlled systemic disease will be treated, with such a stereotactic irradiation, at the same time with evaluation of the local control (Primary endpoint) by repeated MRI and of quality of life, neurologic functionning (with a battery of thsts, e.g. MMSE, QLQ-C30, EORTC BN-20) as well as overall survival as secondary endpoints.

Hypofractionated Brain Radiationcavity

Stereotactic Radiosurgery or Hypofractionated Image-Guided Radiotherapy to the Surgical Cavity After Resection of Brain Metastases: a Multicenter, Single Arm, Open-label, Phase II Trial

Evaluate the recurrence probability in the surgical cavity after radiotherapy

The proportion of surviving patients at 1 year

The proportion of patients with progression of disease in any location other than the brain, according to CTCAE Criteria

Time to neurological deterioration (objective neurological examination and MMSE)

Evaluation of the quality of life through questionnaire

Oncology Institute of Southern Switzerland

Patient receives one research MRI prior to radiation treatment.

MRI Group

Shruti Jolly, MD

Shruti Jolly, M.D.

Currently, appropriate patients undergo MRI imaging with immobilization and sequences optimized for diagnostic radiology purposes. Using a mutual information algorithm, these images are then registered to a treatment planning CT obtained with custom immobilization to minimize intra-and inter-treatment motion and positional variation. This image registration process is time-consuming and introduces additional layers of geometric uncertainty into what should be a highly precise treatment planning process. However, it is necessary, since radiation dose calculations cannot be performed on MRI data due to the lack of crucial density information. The investigator envisions CT-less treatment planning, using only MRI, due to superior imaging characteristics, fully integrated into the radiation oncology clinic. This study will begin this process.

Optimization of MRI for Radiation Therapy

Patients will be off protocol immediately after the single MRI scan. Comparative treatment planning will occur off-line and will not be used for patient care.

University of Michigan Rogel Cancer Center

Rare Diseases

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Dermatologic Agents

Temozolomide

Aminolevulinic Acid

Stereotactic biopsy will be performed on patients in the experimental group, who will then be discharged. If the histopathological diagnosis is not wildtype IDH non-mutated glioblastoma, the patient will be withdrawn from the study and receive conventional treatment. If wildtype IDH non-mutated glioblastoma is diagnosed, ten days after the biopsy, patients will undergo conformal hypofractionated stereotactic radiotherapy to the FLAIR hyperintense signal, including the contrast-enhancing tumor on T1, with a total dose of 3990 cGy at the margin in 15 fractions of 266 cGy, one session per day, five days a week, and concurrent temozolomide (TMZ) at 75 mg/m2/day for 7 days/week during the irradiation period (GEINO, 2016). Five weeks later, patients will undergo supramarginal resection guided by 5-ALA under intraoperative neurophysiological monitoring. Starting from 4 weeks post-surgery, TMZ will be administered for 6 months according to the Stupp protocol.

The Stupp protocol is a standard treatment regimen for glioblastoma, which involves a combination of radiotherapy and chemotherapy.

conformal hypofractionated stereotactic radiotherapy to the FLAIR hyperintense signal, including the contrast-enhancing tumor on T1, with a total dose of 3990 cGy at the margin in 15 fractions of 266 cGy, one session per day, five days a week, and concurrent temozolomide (TMZ) at 75 mg/m2/day for 7 days/week during the irradiation period

hypofractionated stereotactic radiotherapy

Stereotactic biopsy

supramarginal resection guided by 5-ALA under intraoperative neurophysiological monitoring

resection

4 weeks post-surgery, temozolomide (TMZ) will be administered for 6 months

Chemotherapy

radiotherapy + TMZ concurrently after 4 weeks of resection surgery, as per usual protocol: Three-dimensional radiotherapy planning to deliver a total dose of 60 Gy, with a fractionation of 2 Gy/day, 5 days/week, encompassing a 1-2 cm margin around the contrast-enhancing region defined on T1 imaging or the entire abnormal volume defined on T2 or FLAIR imaging (Li et al., 2016) + TMZ at 75 mg/m2/day for 7 days/week, for 6 weeks during radiotherapy.

radiotherapy Stupp protocol

temozolomide (TMZ) will be administered for 6 months according to the Stupp protocol.

Chemotherapy Stupp Protocol

Juan Antonio Barcia

Mª Rebeca Lliguin León

The goal of this clinical trial is to evaluate the safety and efficacy of neoadjuvant radiochemotherapy in the surgical resection of glioblastoma (GBM). The main questions it aims to answer are:

* What is the safety profile of neoadjuvant radiochemotherapy in terms of neurological deficit, radionecrosis, edema, headache, wound dehiscence, infection, and cerebrospinal fluid fistula?
* What is the efficacy of neoadjuvant radiochemotherapy in terms of progression-free survival, overall survival, cognitive function, and quality of life?

Participants will undergo the following tasks and treatments:

* Stereotactic biopsy and diagnosis confirmation.
* Conformal hypofractionated stereotactic radiotherapy with concurrent temozolomide.
* Supramarginal resection guided by 5-ALA under intraoperative neurophysiological monitoring.
* Maintenance temozolomide administration for 6 months.

Researchers will compare the group receiving neoadjuvant radiochemotherapy to the control group following the standard Stupp protocol to assess safety and efficacy outcomes.

Objectives: To study the safety (primary) and efficacy (secondary) of neoadjuvant radiochemotherapy in the surgical resection of glioblastoma (GBM). Safety measures include: neurological deficit, radionecrosis (radiological and clinical), edema, headache, wound dehiscence, infection, and cerebrospinal fluid fistula. Efficacy measures include progression-free survival (PFS), overall survival (OS), cognitive function (MoCA Scale), and quality of life (EuroQol scales, EORTC QLQ-HN35, FACT-Br, and TWiST). Methods: Pilot safety and efficacy study in 6 patients compared to 6 controls. 2-year follow-up. A data safety monitoring committee will review the data one month after surgery for each of the first three patients to decide whether to stop or continue the study. Stereotactic biopsy will be performed, and if GBM is diagnosed, patients will undergo conformal hypofractionated stereotactic radiotherapy to the FLAIR hyperintense signal including the contrast-enhancing tumor on T1, with a total dose of 3990 cGy at the margin in 15 fractions of 266 cGy and concurrent temozolomide (TMZ). 5 weeks later, patients will undergo supramarginal resection guided by 5-ALA under intraoperative neurophysiological monitoring. 7 days after surgery, maintenance TMZ will be administered for 6 months. The control group will follow standard treatment (Stupp protocol). Data analysis will be performed using non-parametric tests. Samples from successive surgeries will be studied with histology, molecular biology, and cell cultures.

Neoadjuvant Radio-chemotherapy Safety Pilot Study in Patients With Glioblastoma

Information on adverse events will be reviewed through direct questioning of the patient.

Information on adverse events will be reviewed through the results of examinations, complementary tests and analytical parameters.

brain RM image, for neuroradiological follow-up

AC_PET image, for neuroradiological follow-up

Progression-free survival (PFS), a measure of how long a patient receives treatment before the cancer begins to grow.

Overall survival (OS), how long patients live after starting treatment.

A commonly used instrument measuring general quality of life (QOL) that reflects symptoms or problems associated with brain malignancies across 5 scales. Patients rate all 5 items using a five-point Likert scale ranging from 0 "not at all" to 4 "very much." Overall, higher ratings suggest higher QOL

It has been shown to be useful at detecting cognitive dysfunction in brain metastases.

The test is a one-page, 30-point test that can be administered in 10 minutes. It assesses short-term memory recall (5 points), visuospatial abilities through clock-drawing (3 points) and cube copy (1 point), and orientation (6 points). Executive function is assessed through modified Trail Making Part B (1 point), phonemic fluency (1 point), and verbal abstraction (2 points). A sustained-attention task (1 point), digit span (2 points), and serial calculation (3 points) test attention, concentration, and working memory. And lastly, language is assessed through naming low-familiarity animals (3 points), sentence repetition (2 points), and the fluency task

Asociación de Afectados Por Tumores Cerebrales en España (ASATE)

Hospital San Carlos, Madrid

Professor

Psychotropic Drugs

6 sessions of individualized CALM therapy

Managing Cancer and Living Meaningfully (CALM) Therapy

Ashlee Loughan, PhD

The purpose of this study is to pilot test an empirically supported psychotherapeutic intervention, Managing Cancer and Living Meaningfully (CALM). Researchers hope to better understand the potential benefits of this intervention on brain tumor patients' mood and quality of life. This may lead to improvements in doctor's understanding of how to enhance brain tumor patient's wellbeing and overall functioning.

In this study, participants will be asked to do the following things:

1. Complete \~15-minute online surveys before the program, immediately after the program (4 months), and at follow-up (6 months). . Questions will ask about mood, anxiety, death distress, quality of social relationships, and satisfaction with life.
2. Meet with an interventionist six times (biweekly) for individual sessions via Zoom, lasting 50-60 minutes each. Sessions will be audio-recorded to ensure all participants receive the same information. Participants will be asked to only use first names.
3. Complete weekly \~5 minute online surveys after each session on satisfaction with the program.
4. Complete an exit interview by telephone approximately 1 month after the 6-session intervention. This exit interview will last approximately 15-30 minutes.

Managing Cancer and Living Meaningfully

Managing Cancer and Living Meaningfully (CALM) in Primary Brain Tumor Patients

Individual level data will not be shared other researchers. Access to all data will be limited to study personnel.

Number of potential participants consented and enrolled

Number of participants completing CALM sessions

Number of participants completing post-session surveys

Number of participants that completed a follow-up survey

Average rating of CALM session satisfaction score (average score across all participants following each CALM session multiple timepoints). Rating option is a range from 1 to 5 with 1 being not at all satisfied and 5 being very much satisfied. Higher scores indicate greater satisfaction.

Average rating of CALM session helpfulness score (average score across all participants following each CALM session multiple timepoints). Rating option is a range from 1 to 5 with 1 being not at all helpful and 5 being very much helpful. Higher scores indicate greater helpfulness.

Average rating of CALM session relevance score (average score across all participants following each CALM session multiple timepoints). Rating option is a range from 1 to 5 with 1 being not at all relevant and 5 being very much relevant. Higher scores indicate greater helpfulness.

Average rating of CALM session utility score (average score across all participants following each CALM session multiple timepoints). Rating option is a range from 1 to 5 with 1 being not at all useful and 5 being very much useful. Higher scores indicate greater helpfulness.

Mean rating of intervention satisfaction score (average score across all participants who completed the CALM intervention - one timepoint). Rating option is a range from 1 to 5 with 1 being not at all satisfied and 5 being very much satisfied. Higher scores indicate greater satisfaction.

Rating of the likelihood of recommending the program to others.

American Cancer Society, Inc.

Virginia Commonwealth University

Adverse events and Serious adverse events were not collected for this trial.

psychotherapeutic intervention

Managing Cancer and Living Meaningfully (CALM) Therapy: 6 sessions of individualized CALM therapy

Therapy

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Ashlee Loughan

Consented

Enrolled

Started intervention

Recruitment for CALM

Completion of CALM Sessions

Post-session Assessment Completion

Follow-up Assessment Completion

Satisfaction With CALM Sessions

Helpfulness of CALM Sessions

Relevance of CALM

Utility of CALM

Intervention Satisfaction

Number of Participants Likely to Recommend the Program to Others

Overall Study

Patients cured of a brain tumour and who have received radiotherapy in childhood

Patients cured of a brain tumour and who have received surgery and/or chemotherapy but were not irradiated

Healthy volunteers (control group) matched in age, manual laterality, gender and parental education to "Patients radiotherapy +"

The MRI protocol is composed of:

* T1-weighted anatomical sequences
* DTI sequences
* resting functional MRI
* 3D MR spectroscopic imaging

Cognitive assessment

Anne LAPRIE, MD

Anne LAPRIE

Brain tumours are the leading cause of cancer-related death and morbidity in children, adolescents and young adults. The brain is also one of the most sensitive organs to treatments used in pediatric oncology, even for cancers not related to the central nervous system. Therapeutic index is therefore a major issue in pediatric neuro-oncology. The efficacy of the therapy as well as its toxicity are difficult to measure using standard tests. In order to optimize therapies that could have an impact on the brain, and consequently on the quality of life of patients, it becomes crucial to optimize the means of evaluation.

Few studies to date have focused on the various components of memory impacted following treatment of a posterior fossa tumour. However, supra-tentorial structures such as the hippocampus, which have long been described for their role in memory, are either partially irradiated (irradiated in their lower part due to their proximity to the target volume during irradiation of the posterior fossa) or completely irradiated (e.g. included in the prophylactic irradiation of medulloblastoma prior to dose supplementation in the posterior fossa). On the other hand, the cerebellum plays a central role in learning and procedural memory involved in motor and cognitive learning, as it enables automation and procedural retention such as reading (automation of the grapho-phonemic conversion procedure) or arithmetic (mental arithmetic).

IMPALA study is aimed at investigating the impact of different irradiation doses received by children treated with radiotherapy on cognitive functions related to the hippocampus and to the cerebellum.

This exploratory study will thus provide elements enabling a better limitation of radiotherapy doses on regions linked to the development of cognition and memory. The project brings together researchers and clinicians with complementary expertise in oncology, neurology and imaging in both children and adults. This study will also provide a better understanding of the role of the cerebellum in memory and executive functions, and develop a method that can then be used in a prospective longitudinal multicentre form.

Memory Neuroimaging in Children, Adolescents and Young Adults Following Pediatric Cancer

Volume of the hippocampus obtained from T1-weighted anatomical

Cortical thickness of the hippocampus obtained from T1-weighted anatomical

Microstructural integrity of the hippocampus obtained from Diffusion Tensor Imaging (DTI) sequences used to calculate the fraction of anisotropy and the mean diffusion sequences

Episodic memory performance of the participants in the different groups when evaluating episodic declarative memory, assessed with Children's Memory Scale in participants under 16 years old and with Wechsler Memory Scale MEM-III in participants over 16 years old (Day 2)

Scores obtained at memory clinical scale for children

Scores obtained at Wechsler Intelligence Scale for Children

Scores obtained at Serial Reaction Time Task

Scores obtained at Peabody Picture Vocabulary Test

Scores obtained at TMT A and B, Stroop Test and Wisconsin Card Sorting Test

Scores obtained at Test of Attentional Performance 2.3.1

Cerebellar volume obtained from T1-weighted anatomical sequences

Micro-structural integrity of the cerebellum achieved by using DTI sequences to calculate the fraction of anisotropy and average diffusivity

Cerebral blood volume obtained from brain perfusion imaging

Post-therapeutic hypoxia as measured by magnetic resonance spectrometry of the hippocampus and cerebellum

Neuronal density as measured by magnetic resonance spectrometry of the hippocampus and cerebellum

Functional connectivity index, obtained via resting functional MRI.

Age at the time of treatment from the patients' medical records

Radiotherapy doses received in the cerebellum, in the hippocampus, and in the whole brain from the patients' medical records

Cerebellum and hippocampus Normal Tissue Complication Probability (NTCP)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Hypofractionated Brain Radiationcavity	NCT03561896	Brain Metastase... Cancer Brain	IGRT SRS	18 Years -	Oncology Institute of Southern Switzerland
Optimization of MRI for Radiation Therapy	NCT02045381	Cancer Liver Cancer Brain Cancer Head &Ne... Cancer Pelvis	MRI Group	18 Years -	University of Michigan Rogel Cancer Center
Neoadjuvant Radio-chemotherapy Safety Pilot Study in Patients With Glioblastoma	NCT06418113	Glioblastoma Glioblastoma Mu... Glioblastoma, I... Radiotherapy; C... Cancer Brain	hypofractionate... Stereotactic bi... resection Chemotherapy radiotherapy St... Chemotherapy St...	18 Years - 75 Years	Hospital San Carlos, Madrid
Managing Cancer and Living Meaningfully	NCT04646213	Mood Cancer Brain	Managing Cancer...	18 Years -	Virginia Commonwealth University
Memory Neuroimaging in Children, Adolescents and Young Adults Following Pediatric Cancer	NCT04324450	Cancer Brain Pediatric Cance...	MRI Cognitive asses...	-	Institut National de la Santé Et de la Recherche Médicale, France
Managing Cancer and Living Meaningfully	NCT04646213	Mood Cancer Brain	Managing Cancer...	18 Years -	Virginia Commonwealth University
Optimization of MRI for Radiation Therapy	NCT02045381	Cancer Liver Cancer Brain Cancer Head &Ne... Cancer Pelvis	MRI Group	18 Years -	University of Michigan Rogel Cancer Center
Hypofractionated Brain Radiationcavity	NCT03561896	Brain Metastase... Cancer Brain	IGRT SRS	18 Years -	Oncology Institute of Southern Switzerland

Spots Global Cancer Trial Database for cancer brain

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