Neoplasms

All Conditions

Head and Neck Neoplasms

Photon intensity modulated radiation therapy (IMRT) to standard dose of 60-66Gy in standard 2 Gy per fraction.

Photon intensity modulated radiation therapy (IMRT)

Proton beam radiotherapy (PBRT) to standard dose of 60-66Gy in standard 2 Gy per fraction.

Proton beam radiotherapy (PBRT)

Nancy Lee, MD

Christopher Barker, MD

Noah Kalman, MD

Robert Foote, MD

Compared to IMRT, PBRT is thought to give less radiation exposure to the surrounding healthy tissues. It is possible that side effect rates with PBRT will be lower or the same compared to IMRT, but this has not been well studied to date. Although both of these radiation therapies have been used in the past to treat head and neck cancer, this research study will compare the effects of these two different radiation treatment modalities with each other to see whether PBRT is better, the same or worse than IMRT.

This is a phase II randomized two-arm trial comparing proton-beam radiation therapy (PBRT) with photon- based intensity-modulated radiation therapy (IMRT) for cancers in the head and neck region requiring ipsilateral radiation.

Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Head and Neck Cancer

A Phase II Randomized Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Unilateral Head and Neck Cancer

Mayo Clinic

Memorial Sloan Kettering Cancer Center

Nervous System Diseases

Behaviors and Mental Disorders

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Quality of Life

A full neurocognitive battery with quality-of-life assessment will be conducted and an rs-fcMRI sequence will be added to the brain MRI performed as standard of care follow-up between 3-5 months post-PBRT.

Healthy participants will be asked to complete the MRI scan and undergo neurocognitive assessment.

Resting-state functional connectivity MRI

Cognitive and quality of life assessments performed by a trained neuropsychologist

Neurocognitive battery with quality-of-life assessment

Andrei Holodny, MD

Stephen Sands, PsyD

The researchers are doing this study to find out if there are differences in the resting state brain networks of children and young adults (ages 6-25) after treatment with proton beam radiation therapy (PBRT). The researchers will use resting state functional connectivity magnetic resonance imagining (rs-fcMRI) scanning to detect these differences. The researchers will also check for differences in participants' thinking and quality of life through a cognitive assessment and a questionnaire. Both people undergoing PBRT for a brain tumor and healthy people will take part in this study so that the researchers can compare the brain networks (connections in the brain that are involved in certain function, such as memory or attention), thinking patterns, and quality of life of these two groups of participants.

The study researchers think that rs-fcMRI scans may be an effective way to look at the brain networks after treatment with PBRT and see if this treatment causes differences in those networks, including damage to the brain (neurotoxicity). rs-fcMRI scans take images when a patient is in a resting state, which means the patient is not performing a task or thinking about anything in particular.

This study will provide valuable information about how PBRT affects brain networks, thinking (cognitive) abilities, and quality of life in children and young adults. The study results may have an impact on future treatment approaches for brain cancer and the use of PBRT in children and young adults.

This prospective, cross-sectional, pilot clinical trial will incorporate rs-fcMRI and a full post- PBRT cognitive battery including quality of life assessment for pediatric patients using a multidisciplinary team.

A Study of How Proton Beam Radiotherapy (PBRT) Affects Brain Function and Quality of Life in Children and Young Adults Undergoing Treatment for a Brain Tumor

Neuroimaging Biomarkers of Impaired Neurocognitive Functioning After Cranial Proton Beam Radiotherapy For Treatment of Brain Tumors In Pediatric Patients

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

A single rs-fcMRI sequence will be added to the MRI performed as standard of care follow-up 3-5 months after completion of cranial PBRT in pediatric patients treated for brain tumors to assess for early post-PBRT network disruption.

Using resting state functional connectivity magnetic resonance imagining (rs-fcMRI) scanning to detect these differences.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Head and Neck Cancer	NCT02923570	Head and Neck C...	Photon intensit... Proton beam rad...	18 Years -	Memorial Sloan Kettering Cancer Center
A Study of How Proton Beam Radiotherapy (PBRT) Affects Brain Function and Quality of Life in Children and Young Adults Undergoing Treatment for a Brain Tumor	NCT05288439	Brain Tumor Metastatic Brai...	Resting-state f... Neurocognitive ...	6 Years - 25 Years	Memorial Sloan Kettering Cancer Center
A Study of How Proton Beam Radiotherapy (PBRT) Affects Brain Function and Quality of Life in Children and Young Adults Undergoing Treatment for a Brain Tumor	NCT05288439	Brain Tumor Metastatic Brai...	Resting-state f... Neurocognitive ...	6 Years - 25 Years	Memorial Sloan Kettering Cancer Center
Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Head and Neck Cancer	NCT02923570	Head and Neck C...	Photon intensit... Proton beam rad...	18 Years -	Memorial Sloan Kettering Cancer Center
A Study of How Proton Beam Radiotherapy (PBRT) Affects Brain Function and Quality of Life in Children and Young Adults Undergoing Treatment for a Brain Tumor	NCT05288439	Brain Tumor Metastatic Brai...	Resting-state f... Neurocognitive ...	6 Years - 25 Years	Memorial Sloan Kettering Cancer Center
Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Head and Neck Cancer	NCT02923570	Head and Neck C...	Photon intensit... Proton beam rad...	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for proton beam radiotherapy (pbrt)