Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Behaviors and Mental Disorders

Carcinoma

Carcinoma, Squamous Cell

Adenocarcinoma

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Quality of Life

Radiation therapy 1 time each day, 5 days a week (Monday through Friday) for up to 28 treatments. 1.8 Gy (or at RBE ("Relative Biologic Equivalence" for PBT)) to be delivered to the periphery of the planning target volume (PTV).

Radiation therapy 1 time each day, 5 days a week (Monday through Friday) for up to 28 treatments. 1.8 Gy to be delivered to the periphery of the planning target volume (PTV).

1.8 Gy (Relative Biologic Equivalence ((RBE)) to be delivered to the periphery of the planning target volume (PTV) 1 time each day, 5 days a week (Monday through Friday) for up to 28 treatments.

Proton Beam Therapy (PBT)

1.8 Gy to be delivered to the periphery of the planning target volume (PTV) 1 time each day, 5 days a week (Monday through Friday) for up to 28 treatments.

Intensity Modulated Radiation Therapy (IMRT)

Symptom and Quality of Life questionnaires completed at baseline, every week during radiation therapy, during break after radiation therapy, and during follow up phase.

Questionnaires

Steven H. Lin, MD,PHD

The goal of this clinical research study is to learn how safe and effective proton-beam therapy (PBT) may be in comparison to intensity modulated radiation therapy (IMRT) in combination with chemotherapy in patients with esophageal cancer.

PBT and IMRT are both forms of radiation therapy that are designed to treat a specific area of the body while affecting as little of the surrounding normal tissue as possible. PBT is a newer technology that is designed to further reduce the amount of radiation that affects the surrounding normal tissue. However, this is still being studied.

Study Treatment:

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:

* If you are in Group 1, you will receive IMRT.
* If you are in Group 2, you will receive PBT.

You will receive radiation therapy 1 time each day, 5 days a week (Monday through Friday) for up to 28 treatments.

Your doctor may think it is in your best interest to also receive chemotherapy while you are receiving radiation therapy. If this occurs, you will sign a separate consent form for these drugs with a full description of how they are given and the risks they may cause.

Study Visits:

Before you begin receiving radiation therapy, you will have a baseline visit. The following tests and procedures will be performed:

* Blood (about 1-2 tablespoons) will be drawn for routine tests.
* Your performance status will be recorded.
* You will have a PET/CT or CT scan to check the status of the disease.
* You will have lung function tests
* You will complete the symptom and quality of life questionnaires.
* Your esophagus will be examined using an endoscope. If the doctor thinks it is needed, you will have a biopsy to check the status of the disease.

You will then have a study visit every week while you are receiving radiation therapy. The following tests and procedures will be performed:

* Your medical history will be recorded.
* You will have a physical exam.
* Your performance status, weight, and vital signs will be recorded.
* Blood (about 1-2 tablespoons) will be drawn for routine tests.
* You will complete the symptom and quality of life questionnaires.

Length of Study:

You will receive radiation therapy for up to 28 treatments (about 5½ weeks). 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 participation on the study will be over once you have completed the follow-up visits.

Follow-Up:

After you stop receiving radiation therapy, there will be a 4-6 week break. During this time, you will contacted 2 times each week to complete the symptom and quality of life questionnaires. You will receive a call from an automated calling service or from the study staff at a scheduled time of your choosing. You will continue to be followed routinely during treatment and for follow-up visits and tests.

About 4-6 weeks after you stop receiving radiation therapy, the following tests and procedures will be performed:

* Your medical history will be recorded.
* You will have a physical exam.
* Your performance status, weight, and vital signs will be recorded.
* You will have a PET/CT scan to check the status of the disease.
* You will have lung function tests.
* Blood (about 1-2 tablespoons) will be drawn for routine tests.
* You will complete the symptom and quality of life questionnaires.
* Your esophagus will be examined using an endoscope. If the doctor thinks it is needed, you will have a biopsy to check the status of the disease.

If your doctor thinks it is in your best interest after you have completed radiation therapy, you will have surgery to remove the tumor. You will sign a separate consent form that describes the procedure and its risks. As part of this study, the study doctor will check you for side effects and discomfort after the surgery.

Every 3-4 months for 2 years, and then every 4-6 months for the next 3 years, you will have follow-up visits. The following tests and procedures will be performed:

* Your medical history will be recorded.
* You will have a physical exam.
* Your performance status, weight, and vital signs will be recorded.
* You will have either a CT or a PET/CT scan to check the status of the disease.
* You will complete the symptom and quality of life questionnaires. (If the disease gets worse, these questionnaires will no longer be completed.)

Additionally, the following tests and procedures will be performed at follow-up visits only when the doctor thinks they are needed:

* Blood (about 1-2 tablespoons) may be drawn for routine tests.
* You may have lung function tests.
* Your esophagus will be examined using an endoscope. If the doctor thinks it is needed, you will have a biopsy to check the status of the disease.

You may be contacted by the study staff to ask about your health, even if you choose not to return to MD Anderson for follow-up visits after completing treatment for esophageal cancer.

This is an investigational study. IMRT and PBT are delivered using FDA-approved and commercially available methods. It is investigational to compare IMRT to PBT.

Up to 180 patients will take part in this study. All will be enrolled at MD Anderson.

Proton Beam Therapy (PBT) Versus Intensity-Modulated Radiation Therapy (IMRT) Trial

Phase IIB Randomized Trial of Proton Beam Therapy Versus Intensity-Modulated Radiation Therapy for the Treatment of Esophageal Cancer

Defined from the time of enrollment to the date of death or any recurrence. The progression-free survival (PFS) time distribution will be estimated in each treatment arm using the Kaplan-Meier method.

TTB defined from the time of randomization to 12 months after randomization. Total toxicity burden (TTB) is computed as a composite score from serious adverse events (SAEs) and, among patients who undergo surgery, postoperative complications (POCs).

Massachusetts General Hospital

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Symptoms and General Pathology

Nervous System Diseases

Fatigue

Glioma

Parasomnias

Brain Neoplasms

Astrocytoma

Oligodendroglioma

Dyssomnias

Ependymoma

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Anaplastic Astrocytoma

Anaplastic Oligodendroglioma

Oligoastrocytoma

Anaplastic Oligoastrocytoma

Anaplastic Ependymoma

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Melatonin

A total of 8 questionnaires regarding fatigue taking approximately 30 minutes each, given before radiation therapy, weekly during, and after completion.

Questionnaire

Mark R. Gilbert

This goal of this research study is to learn more about fatigue, sleep quality, and other symptoms in patients with primary brain tumors who are being treated with radiation therapy.

Objectives:

PRIMARY OBJECTIVE:

1. The primary objective of this study is to provide preliminary data describing the severity and change over time in fatigue using the Brief Fatigue Inventory (BFI) during radiation therapy for patients with primary gliomas.

SECONDARY OBJECTIVES:

1. To evaluate longitudinal changes in the severity of symptoms and the mean symptom burden as measured by the M.D. Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) and mood using the Profile of Mood States (POMS) during radiation therapy.
2. To assess alterations in circadian rhythms using actigraphy during radiation therapy and the association with sleep quality tools - Pittsburgh Sleep Quality Index (PSQI) and the Epworth Sleepiness Scale(ESS), and the severity of BFI and MDASI-BT scores over time.
3. To explore the association between the levels of salivary hormones (melatonin and cortisol) and the occurrence of fatigue and symptom burden.

Questionnaires:

If you decide to take part in this study, before starting radiation therapy, weekly during radiation therapy, and again 3-4 weeks and 6-8 weeks after completing radiation therapy, you will complete 4 questionnaires. Three (3) of the questionnaires will be completed during a study visit, and the last 1 will be completed at home the next time you come into the clinic. You will return the questionnaire completed at home to the study doctor at a study visit. The questionnaires will ask questions about fatigue, any symptoms you may have, and your sleeping habits. It should take about 30 minutes total to complete all of the questionnaires each time.

Sleep Diary:

You will complete a sleep diary. The sleep diary will be provided to you before starting radiation therapy. You will record information in it about your sleep habits, caffeinated beverages and drugs you may take, the quality of your sleep, and how you feel when you wake up. You will complete the sleep diary during the 48 hours that you are wearing the actigraphy watch. You will bring the sleep diary to the clinic every week for the study doctor to review.

Actigraphy Watch:

You will wear an actigraphy watch on your wrist for 48 hours before starting radiation therapy, for 48 hours each week during radiation therapy, and again for 48 hours 3-4 weeks and 6-8 weeks after completing radiation therapy. The actigraphy watch will measure your activity during the day and night. You will bring the actigraphy watch to the clinic every week for the study doctor to review.

Saliva Collection:

You will collect a saliva sample four times during the day before starting radiation therapy, one time during the third and last week of radiation therapy, and again 3-4 weeks and 6-8 weeks after completing radiation therapy. These samples will be used to measure levels of neurotransmitters and hormone levels. These are substances which are released in the body that may affect sleep and the immune system.

Length of Study:

You will remain on study for about 8 weeks after you complete radiation therapy.

This is an investigational study. Up to 20 patients will take part in this study. All will be enrolled at M.D. Anderson.

Fatigue, Sleep and Cytokines in Primary Brain Tumor (PBT) Patients

Relationship Among Fatigue, Symptoms, Melatonin and Sleep in PBT Patients Undergoing Radiation Therapy

Skin and Connective Tissue Diseases

Breast Neoplasms

Fibrosis

Breast Diseases

Skin Diseases

Participants will be randomized 1:1 to XRT group and stratified by receipt of chemotherapy and cardiac risk factors and will complete:

* Cardiac MRI and blood tests within 1 month prior to start of radiation therapy.
* Radiation therapy 1x daily for 5 days over 1 week.
* End of radiation therapy visit with blood tests.
* 6 month follow up visit with cardiac MRI, blood tests, questionnaires, and photographic imaging.
* 12 month follow up visit with questionnaires and photographic imaging.

Accelerated Proton Beam Radiation Therapy (PBT)

Accelerated Photon Radiation Therapy (XRT)

Rachel Jimenez, MD

This research is being done to see if proton beam radiation therapy (PBT) results in fewer changes to a participant's heart measured with MRI-imaging than conventional or "photon" radiation therapy (XRT) for participants with non-metastatic left sided breast cancer.

The names of the two study groups in this research study are:

* Proton Radiation Therapy (PBT)
* Conventional or "Photon" Radiation Therapy (XRT)

This is a randomized phase II trial comparing participants with stage II-III breast cancer treated with accelerated Proton Beam Radiation Therapy (PBT) versus accelerated conventional photon radiation therapy (XRT) inclusive of the regional lymph nodes.

Participants will be randomized into one of two study groups: proton beam radiation therapy versus photon radiation therapy. Randomization means that participants are put into a group by chance.

Study procedures includes screening for eligibility, study treatment visits, Cardiac Magnetic Resonance Imaging (MRI), blood tests, and questionnaires.

The National Cancer Institute, American Society of Clinical Oncology, and Claflin Grant are supporting this research by providing funding for the research study.

All women of all races and ethnic groups are eligible for this trial.

Ultrahypofractionation and Normal Tissue Toxicity

Proton Versus Photon Ultrahypofractionated Radiation Therapy and Its Impact on Normal Tissue

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

The primary outcome is to determine whether participants who receive accelerated PBT show no increase in myocardial fibrosis on Cardiac MRI (CMR) compared to an estimated 4% increase in extracellular matrix volume fraction (ECV) in participants who receive accelerated XRT. CMR will be performed using a 3T system (Skyra, Siemens). The T1 phase on MRI will be used to measure ECV.

GLS will be measured using feature tracking from the Steady-state free precession (SSFP) MRI cine images (Medis Suite, Leiden).

Cardiac Biomarkers will be measured using enzyme-linked immunoassay (ELISA).

Assessed by photographic imaging of the breast, chest wall and reconstructed breast, the Breast Q: Mastectomy Module (Postoperative) 2.0, the Breast Q: Reconstruction Module (Postoperative) 2.0, and the Breast-Q: Breast Conserving Therapy Module (Postoperative) 2.0 questionnaires which are rigorous patient-report outcome measures. Modules grade Quality of Life (QOL) and Satisfaction Domains related to post-operative care and experiences. All BREAST-Q scales are transformed into scores that range from 0-100. T. A higher score means greater satisfaction or better QOL (depending on the scale).

Assessed by the Thoracic Focused Assessment with Sonography for Trauma, Triage, and Tracking (TFAST), the Penn Shoulder Scale (PSS), and the Disabilities of the Arm, Shoulder and Hand (DASH) Shoulder Function Scale. TFAST is an objective and highly reproducible functional assessment tool of the arm and shoulder. The PSS is a patient-reported outcome tool which provides a shoulder-specific metric and distinguishes between finer levels of functioning. Scores range from 0 to 100 with a score of 100 indicating low pain, high satisfaction, and high function. DASH is a 30-item, validated, patient-reported scale that captures upper extremity functionality and mobility and maintains high construct validity and responsiveness in the breast cancer population. Questions are graded on a Likert scale with scores ranging from "1" Strongly Disagree to "5" Strongly Agree, where a cumulative score of 0 is graded no disability and 100 is most severe disability.

American Society of Clinical Oncology

Principal Investigator

Sleep Initiation and Maintenance Disorders

Sleep Disorders, Intrinsic

Sleep Wake Disorders

Mental Disorders

Psychotic Disorders

Group intervention; topics include psychoeducation about sleep, sleep restriction, stimulus control, relaxation strategies, and cognitive restructuring.

Cognitive Behavioral Therapy-Insomnia

Ashlee Loughan, PhD

The purpose of this study is to pilot test an empirically supported psychotherapeutic intervention, Cognitive Behavior Therapy for Insomnia (CBT-I) in primary brain tumor patients. Researchers hope to better understand the feasibility and acceptability of this intervention in neuro-oncology, as well as the preliminary potential benefits of this intervention on brain tumor patients' sleep, fatigue, mood, quality of life, and chronic inflammation. This may lead to improvements in treating insomnia in primary brain tumor patients.

The present study design is a pilot within-subjects pre-/post-evaluation of feasibility, acceptability, and preliminary efficacy of the Cognitive Behavioral Therapy for Insomnia (CBT-I) intervention for primary brain tumor patients. In this study, participants will be asked to do the following things:

* Meet with a trained interventionist six times (biweekly) for group CBT-I sessions via Zoom, lasting 90 minutes each. Participants will be asked to only use first names and will complete weekly sleep diaries as part of the intervention.
* Complete \~20-minute online surveys before the program, immediately after the program (6 weeks), and at follow-up (3 months). Questions will ask about subjective sleep, fatigue, mood, and quality of life. The follow-up time point will also ask about the patient's satisfaction with the CBT-I program.
* Complete a brief (15 minute) cognitive evaluation before and immediately following the program.
* Wear a wrist-worn actigraphy monitor one week prior to the 6-week CBT-I intervention and one week following completion of the intervention.
* Patients currently receiving regular blood draws as part of their care at Massey Cancer Center will have an IL-6 added to their regular blood draw. THose who are not receiving regular blood draws as part of their standard of care OR those who are not patients at Massey Cancer Center will forego this part of the intervention.

CBT for Insomnia in Primary Brain Tumor Patients

Cognitive Behavioral Therapy for Insomnia in Primary Brain Tumor Patients

Currently there is no plan in place to share data with other researchers.

Determine how many patients consent to screening after referral to the program, how many patients are eligible for the program after being screened, and how many consent/enroll in the program if eligible.

Percent of sessions attended by consented participants

Percent of post-session surveys completed by participants immediately after the intervention

Percent of follow-up surveys completed by participants three months after the intervention

Program satisfaction questions are measured on a 10-point Likert scale with 1 being not at all satisfied and 10 being very much satisfied. Higher scores indicate greater program satisfaction.

Total sleep time gathered by the participant from a wrist-worn Actigraph

Percent of time spent in bed / time asleep gathered by the participant from a wrist-worn Actigraph

Total sleep time gathered from a participant-reported sleep diary

Determine the degree of participant insomnia using the Insomnia Severity Index, a brief self-report questionnaire measured on a 5-point Likert scale (0 = None, 4 = Very Severe). Higher scores indicate greater subjective insomnia.

Determine the degree of participant sleep disturbance using the Pittsburgh Sleep Quality Index, a brief self-report questionnaire. Higher scores indicate greater global sleep disturbance.

Request that participants self report how many hours a day they nap on average using one self-report question (During the past month, how many hours did you nap during a typical day?)

Determine participants' level of fatigue using the Brief Fatigue Inventory, a self-report questionnaire measured on a 11-point Likert scale (0 = No Fatigue/Does Not Interfere; 10 = As Bad as You Can Imagine/Completely Interferes). Higher scores indicate greater symptoms of fatigue.

Determine the extent of depressive symptoms using the Patient Health Questionnaire-9, a brief-self report questionnaire measured on a 4-point Likert scale (0 = Not at All; 3 = Nearly Everyday) Higher scores indicate greater symptoms of depression.

Determine the extent of anxiety symptoms using the Generalized Anxiety Disorder-7, a self-report questionnaire measured on a 4-point Likert scale (0 = Not at All; 3 = Nearly Everyday). Higher scores indicate greater symptoms of anxiety.

Determine the level of participant's death anxiety using the Death and Dying Distress Scale, a self-report questionnaire measured on a 6-point Likert scale (0 = Not Distress; 5 = Extreme Distress). Higher scores indicate greater symptoms of death anxiety.

Determine participants' level of quality of life using the EORTC-QoL-C30, a self-report questionnaire measured on a 4-point Likert scale (1 = Not at All; 4 = Very Much). Higher scores indicate lower overall quality of life.

Determine the level of inflammation as measured by the amount of Cytokine Interleukin-6 (IL-6) in the participant's blood; only participants receiving regular blood draws as part of their routine will have this data

Participants' speed of thinking will be assessed by administering the Trail Making Test A, a neuropsychological assessment tool

Measure executive functioning by administering the Trail Making Test B, a neuropsychological assessment tool

Participants' language fluency will be measured using the Controlled Oral Word Association Test, a neuropsychological assessment tool

Participants' ability learn/ memory will be assessed by administering the Hopkins Verbal Learning Test, a neuropsychological assessment tool

Participants are requested to self-report on their age, gender identity, race/ethnicity, and level of education

Information on participants' tumor diagnosis, treatment history, and medications will be from the participants' medical charts to determine brain tumor characteristics

Virginia Commonwealth University

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Data collection on patients being treated with thoracic reirradiation with PBT or IMRT for NSCLC, with or without chemotherapy.

Data collected in the registry includes patient characteristics/demographics, disease characteristics, treatment details (radiation, chemotherapy, surgery, etc.), toxicity rates, and survival outcomes.

Thoracic Reirradiation Registry

Daniel Gomez, MD

The goal of this research study is to learn more about the safety of treating NSCLC with reirradiation using standard methods and to look for ways to lessen side effects and improve therapy. Reirradiation is when radiation is given to an area of the body that has previously received a full dose of radiation.

If you agree to take part in this study, data will be recorded during your therapy. The data to be recorded will include your medical history, the disease, treatments you have received and how you have responded to any treatments, as well as any side effects you may have had.

The data will be stored on a password-protected computer at MD Anderson for use in future research related to cancer.

Your data will be given a code number. No identifying information will be directly linked to your data. Only the researcher in charge of this study will have access to the code numbers and be able to link the data to you. This is to allow medical information related to your data to be updated as needed. Other researchers using your data will not be able to link this data to you.

Length of Study:

After you sign this consent form, your active participation on this study will be over.

This is an investigational study.

Up to 120 patients will take part in this study. All will be enrolled at MD Anderson.

Registry Study of Thoracic Reirradiation for Non-Small Cell Lung Cancer (NSCLC) Utilizing Proton Beam Therapy or Intensity Modulated Radiation Therapy

Primary objective to assess the prevalence of high-grade toxicity in patients being treated with thoracic reirradiation with proton beam therapy (PBT) or intensity modulated radiation therapy (IMRT) for non-small cell lung cancer (NSCLC), with or without chemotherapy. High-grade toxicity defined as CTCAE v4.0 Grade 3 or higher toxicity, or CTCAE v4.0 grade 4 or higher toxicity of the esophagus. Data collected from 1/2/2012 to 1/31/2017. High-grade toxicity rate and its corresponding 95% confidence interval provided at end of study. Logistic regression model used to assess the association between prognostic factors such as total dose to normal tissue structures, time since initial course of RT, failure in same lobe of the lung, failure in nodal regions, and central vs. peripheral location and high-grade toxicity.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Proton Beam Therapy (PBT) Versus Intensity-Modulated Radiation Therapy (IMRT) Trial	NCT01512589	Esophageal Canc...	Proton Beam The... Intensity Modul... Questionnaires	18 Years -	M.D. Anderson Cancer Center
Fatigue, Sleep and Cytokines in Primary Brain Tumor (PBT) Patients	NCT00876499	Brain Cancer	Questionnaire	18 Years -	M.D. Anderson Cancer Center
Ultrahypofractionation and Normal Tissue Toxicity	NCT05912231	Breast Cancer Breast Cancer F... Breast Cancer S... Breast Cancer S... Myocardial Fibr...	Accelerated Pro... Accelerated Pho...	18 Years -	Massachusetts General Hospital
CBT for Insomnia in Primary Brain Tumor Patients	NCT04919993	Primary Brain T... PBT	Cognitive Behav...	18 Years -	Virginia Commonwealth University
Registry Study of Thoracic Reirradiation for Non-Small Cell Lung Cancer (NSCLC) Utilizing Proton Beam Therapy or Intensity Modulated Radiation Therapy	NCT01808677	Non-Small Cell ...	Thoracic Reirra...	18 Years -	M.D. Anderson Cancer Center
Proton Beam Therapy (PBT) Versus Intensity-Modulated Radiation Therapy (IMRT) Trial	NCT01512589	Esophageal Canc...	Proton Beam The... Intensity Modul... Questionnaires	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for pbt

Every month we try and update this database with for pbt 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 pbt

Every month we try and update this database with for pbt 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 pbt 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.