Neoplasms

All Conditions

Nervous System Diseases

Behaviors and Mental Disorders

Rare Diseases

Glioblastoma

Brain Neoplasms

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

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Quality of Life

Neuroepithelioma

IMPT treatments delivered as once daily fractions, 5 days per week Monday - Friday for 30 treatments.

IMRT treatments delivered as once daily fractions, 5 days per week Monday - Friday for 30 treatments.

IMPT

IMRT

Cognitive tests given at baseline, 4 months, then every 2 months for 2 years.

Cognitive Tests

Questionnaires about quality of life and symptoms given at baseline, 4 months, then every 2 months for 2 years.

Questionnaires

Caroline Chung, MD

The goal of this clinical research study is to compare IMRT with IMPT in patients with glioblastoma. Researchers want to learn about cognitive side effects (mental status changes) that may occur, such as memory loss and impaired thinking.

IMRT is the delivery of focused radiation therapy using photon beams and advanced computer planning to help shape the dose in order to give the highest possible dose to the tumor with the least dose to surrounding normal tissues.

IMPT is also focused radiation therapy similar to IMRT, but it uses proton particles to deliver the radiation instead of photon beams. IMPT also uses advanced computer planning in order to shape the dose to the target with the least dose to surrounding normal tissues.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. You will have an equal chance of being assigned to either group.

If you are in Group 1, you will receive IMRT.

If you are in Group 2, you will receive IMPT.

Radiation Therapy:

In both groups, you will receive radiation treatments each day, Monday-Friday, starting on Day 1. You will continue to receive radiation treatment until you have completed 30 total treatments. This is a total of up to 6 weeks of treatment.

You will sign a separate consent form for the IMRT or IMPT that will explain the procedures and risks in detail.

Study Visits:

Before beginning radiation, you will have what is called a "simulation" to plan your radiation. During the simulation, you will be flat on your back on a computed tomography (CT) table and a soft plastic mask will be made to help hold your head still during treatment. This is the position you will be in when you receive radiation treatment. You will then have a CT scan, which will make computerized images to help plan your treatment.

At Month 2 (+/- 30 days):

* You will have a physical exam, including measurement of your vital signs.
* You will have an MRI to check the status of the disease.
* You will be asked about any drugs you may be taking and side effects you may be having.
* You will complete the thinking skills tests and the questionnaires about your quality of life and symptoms.

Length of Treatment:

You may receive up to 6 weeks of radiation therapy. You will no longer be able to receive radiation therapy if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your active participation on the study will be over after the follow-up visits.

Follow-Up:

At Month 4 (+/- 30 days) and then every 2 months for up to 2 years after radiation therapy:

* You will have a physical exam, including measurement of your vital signs.
* You will be asked about any side effects you may be having.
* You will have an MRI to check the status of the disease.
* You will complete the thinking skills tests and the questionnaires about your quality of life and symptoms.

Starting 2 years after radiation therapy, the study staff will continue checking your medical record to find out about your health status from then on.

This is an investigational study. IMRT is delivered using FDA-approved and commercially available methods. IMPT is investigational.

Up to 90 participants will be enrolled in this study. All will be enrolled at MD Anderson.

Glioblastoma Multiforme (GBM) Proton vs. Intensity Modulated Radiotherapy (IMRT)

A Prospective Phase II Randomized Trial to Compare Intensity Modulated Proton Radiotherapy (IMPT) vs. Intensity Modulated Radiotherapy (IMRT) for Newly Diagnosed Glioblastoma (WHO Grade IV)

Time to cognitive failure on any of 6 primary variables from pre-specified cognitive tests (HVLT-R total recall, HVLT-R delayed recall, HVLT-R delayed recognition, TMT Part A or Part B, COWA) with failure defined as a decline that meets or exceeds the reliable change index (RCI) for each cognitive test variable. A cumulative incidence approach used to estimate median time to cognitive failure in order to account for the competing risks of disease progression and death.

Overall survival time is defined as time from registration/randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method.

Measured from date of registration to date of first observation of progressive disease, symptomatic deterioration or death due to any cause. Participants last known to be alive and progression-free are censored at date of last contact.

The adverse severity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v4.0).

Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL

Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL

Grade 4 Life-threatening consequences; urgent intervention indicated.

Count of participants experiencing adverse events. Should a participant experience multiple adverse events at different grades, the patient is counted only once at the highest grade.

M.D. Anderson Cancer Center

During this study, both the Intensity Modulated Radiotherapy (IMRT) and Intensity Modulated Proton Radiotherapy (IMPT) arms reported serious and life-threatening adverse events. Specifically, 2 participants in the IMRT arm and 1 participant in the IMPT arm experienced Grade 4 life-threatening events that required urgent intervention

IMRT treatments delivered as once daily fractions, 5 days per week Monday - Friday for 30 treatments.

IMRT: IMRT treatments delivered as once daily fractions, 5 days per week Monday - Friday for 30 treatments.

Cognitive Tests: Cognitive tests given at baseline, 4 months, then every 2 months for 2 years.

Questionnaires: Questionnaires about quality of life and symptoms given at baseline, 4 months, then every 2 months for 2 years.

Intensity Modulated Radiotherapy (IMRT)

IMPT treatments delivered as once daily fractions, 5 days per week Monday - Friday for 30 treatments.

IMPT: IMPT treatments delivered as once daily fractions, 5 days per week Monday - Friday for 30 treatments.

Cognitive Tests: Cognitive tests given at baseline, 4 months, then every 2 months for 2 years.

Questionnaires: Questionnaires about quality of life and symptoms given at baseline, 4 months, then every 2 months for 2 years.

Intensity Modulated Proton Radiotherapy (IMPT)

Total

Age, Continuous

Sex: Female, Male

White

Hispanic

African American

Asian

Race/Ethnicity, Customized

United States

Region of Enrollment

Between June 2013 and March 2016, 90 patients consented to participate and 67 were treated (28 PT, 39 IMRT) with the majority of patients excluded before treatment began due to insurance denial of proton therapy

Dr. Caroline Chung, MD- VP, Chief Data Officer, Data Impact & Governance

Time to Cognitive Failure

Between June 2013 and March 2016, 90 participants consented to participate and 67 (41 and 26 participants effectively treated with IMRT and IMPT) were treated with the majority of participants excluded before treatment began due to insurance denial of proton therapy.

Overall Survival

Between June 2013 and March 2016, 90 patients consented to participate and 67 (41 and 26 participants effectively treated with IMRT and IMPT) were treated with the majority of participants excluded before treatment began due to insurance denial of proton therapy.

Progression Free Survival (PFS)

Grade 4 Adverse Events

Grade 3 Adverse Events

Grade 2 Adverse Events

Number of Participants Experienced Adverse Events by Maximum Grade (Grade 2 or Higher)

Overall Study

Mouth and Tooth Diseases

Carcinoma

Carcinoma, Squamous Cell

Mouth Neoplasms

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Oral Cancer

Symptom questionnaires about symptoms of cancer and how they affect life at work and at home, diet, and speech completed at baseline, every week during IMPT, at 3 months, and at 6 months.

Dysphagia Inventory questionnaire about how difficult it is to swallow completed at baseline, every week during IMPT, at 3 months, and at 6 months.

Activity bands given to participant at baseline. Participant wears the band 24 hours a day for 1 week leading up to all study visits.

Symptom questionnaires about symptoms of cancer and how they affect life at work and at home, diet, and speech completed at baseline, after TORS, at 3 months, and at 6 months.

Dysphagia Inventory questionnaire about how difficult it is to swallow completed at baseline, after TORS, at 3 months, and at 6 months.

Activity bands given to participant at baseline. Participant wears the band 24 hours a day for 1 week leading up to all study visits.

Intensity-Modulated Proton Therapy or( IMPT) Group: Symptom questionnaires about symptoms of cancer and how they affect life at work and at home, diet, and speech completed at baseline, every week during IMPT, at 3 months, and at 6 months.

TransOral Robotic Surgery (TORS) Group: Symptom questionnaires about symptoms of cancer and how they affect life at work and at home, diet, and speech completed at baseline, after TORS, at 3 months, and at 6 months.

Symptom Questionnaires

Intensity-Modulated Proton Therapy or( IMPT) Group: Dysphagia Inventory questionnaire about how difficult it is to swallow completed at baseline, every week during IMPT, at 3 months, and at 6 months.

TransOral Robotic Surgery (TORS) Group: Dysphagia Inventory questionnaire about how difficult it is to swallow completed at baseline, after TORS, at 3 months, and at 6 months.

Dysphagia Inventory Questionnaire

Activity bands given to participant at baseline. Participant wears the band 24 hours a day for 1 week leading up to all study visits.

Activity Bands

Neil Gross, MD

MD Anderson Health Information Specialist

The goal of this laboratory research study is to learn about symptoms and activity levels of patients with OPSCC that receive IMPT or TORS.

Baseline Visit:

If participant agrees to take part in this study, they will complete the following tests and procedures at their baseline visit. This baseline visit will take place before participant's treatment with IMPT or TORS:

* Participant will complete questionnaires about any symptoms of cancer they may be having and how they affect their daily life at work and at home, their diet, and their speech.
* Participant will complete the Dysphagia Inventory. This is a questionnaire about how difficult it is to swallow.
* The study staff will measure how wide participant can open their jaw to see if their treatment may cause any jaw opening limitations.

It should take about 30 minutes to complete all of the questionnaires.

As part of participant's baseline visit, information below will be collected from their medical record:

* Participant's medical history
* The results of participant's physical exam including their weight and any recent weight loss.
* Any other diseases participant may have and any drugs they are currently taking.
* Participant's current smoking status and smoking history.

Activity Bands:

The study staff will either give participant an activity band at their baseline visit or they will be mailed an activity wristband. Participant will be asked to wear the band 24 hours a day for 1 week leading up to all study visits. The wristband will record how active participant is and how much they sleep. The study staff will show participant how to wear and use the wristband.

Study Visits:

Participant will complete the following study procedures after they complete treatment with either IMPT or TORS, and at 3 and 6 months after that.

* The data from participant's wristband will be collected.
* Participant will complete the same questionnaires they did at baseline.
* At participant's 3 month visit only, the study staff will measure how wide they can open their jaw to see if their treatment may cause any jaw opening limitations.

IMPT patients only:

If participant is receiving IMPT, they will complete the questionnaires they completed at the baseline visit once a week while they are receiving treatment.

Length of Study:

Participant's active participation in this study will be over after the 6 month study visit.

Participant will return the wristband to the study staff after their participation is over. If participant loses or damages the wristband while they are on study, another one will be provided to them at no cost.

This is an investigational study.

Up to 44 participants will take part in this study. All will be enrolled at MD Anderson.

Intensity-Modulated Proton Therapy (IMPT) or TransOral Robotic Surgery (TORS) for the Treatment of Low-Risk Oropharynx Squamous Cell

Observational Parallel Cohort Study of Intensity-Modulated Proton Therapy (IMPT) or TransOral Robotic Surgery (TORS) for the Treatment of Low-Risk Oropharynx Squamous Cell Carcinoma

Functional outcome measured by using longitudinal digital wristband activity monitoring of study participants.

Functional outcome measured by using patient-reported outcome (PRO) measures from the M.D. Anderson Symptom Inventory for Head and Neck Cancer (MDADI-HN).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Glioblastoma Multiforme (GBM) Proton vs. Intensity Modulated Radiotherapy (IMRT)	NCT01854554	Brain Cancer	IMPT IMRT Cognitive Tests Questionnaires	18 Years -	M.D. Anderson Cancer Center
Glioblastoma Multiforme (GBM) Proton vs. Intensity Modulated Radiotherapy (IMRT)	NCT01854554	Brain Cancer	IMPT IMRT Cognitive Tests Questionnaires	18 Years -	M.D. Anderson Cancer Center
Intensity-Modulated Proton Therapy (IMPT) or TransOral Robotic Surgery (TORS) for the Treatment of Low-Risk Oropharynx Squamous Cell	NCT02663583	Cancer of the M... Oropharynx Squa...	Symptom Questio... Dysphagia Inven... Activity Bands	18 Years -	M.D. Anderson Cancer Center
Intensity-Modulated Proton Therapy (IMPT) or TransOral Robotic Surgery (TORS) for the Treatment of Low-Risk Oropharynx Squamous Cell	NCT02663583	Cancer of the M... Oropharynx Squa...	Symptom Questio... Dysphagia Inven... Activity Bands	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for impt

Every month we try and update this database with for impt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for impt

Every month we try and update this database with for impt cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for impt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.