Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Digestive System Diseases

Rare Diseases

Lung Neoplasms

Esophageal Neoplasms

Mesothelioma

Mesothelioma, Malignant

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Mesothelial

Esophageal Cancer

Malignant Mesothelioma

Our plan is to analyze 3-5 tissue probes acquired from 30 patients with a variety of thoracic malignancies. The investigators will plan to acquire tissue from each type of malignancy including: lung cancer, esophageal cancer and pleural based tumors. Tissue will be acquired in the operating room. Impedance measurements will be collected on multiple sections of excised tissue and will be translated into dielectric properties. After acquisition of data, the investigators will assess the data and continue to acquire patients to obtain significant estimates of overall tissue properties in each type of tumor. After undergoing an informed consent process in accordance with IRB approval, patients with be formally enrolled. All tumor electric property data will be stored securely and remain anonymous of patient identifying data.

The LCR meter is used for electric property analysis of tissues. It works by measuring impedance on multiple sections of excised tissue and translating those measurement into dielectric properties.

LCR Meter (Brand: Keysight, Serial Number:E498AL)

Melissa Culligan, RN, MSc

Grace Patrice Anyetei-Anum, MS

Joseph Friedberg, MD, FACS

The purpose of the Dielectrics Properties of Thoracic Malignancies Study (DPTMS) is to provide a wealth of knowledge for investigators involved in establishing a new and effective treatment for a variety of solid tumors using tumor treatment fields. It is intended to provide biospecimen (tumor/healthy) together with demographic data (age, sex, race, occupational history, and other epidemiologic information), and clinical data (stage, treatment, survival information, and annotated CT's). Our specific aims are to test the following hypotheses: 1) Electric properties of thoracic tumors differ from electric properties of surrounding healthy tissue 2) Different tumor types will have different electric properties 3) Electric properties of individual tumors are heterogeneous 4) Electric properties of tumors are related to the structure and composition of the underlying tissue 5) Use of standard medical imaging data (CT) will permit mapping of electric properties.

Thoracic malignancies represent a significant burden of disease in the US population. Lung cancer, for example, is the most common cause of cancer mortality in the US among both men and women and long-term survival remains poor with a 5-year survival rate less than 20%. There is significant need for additional therapeutic options for all stages of patients. Esophageal cancer, although less common in the US with an incidence of 1% among new cancer diagnosis, also has significant mortality with a similar survival rate of about 20% at 5 years. There are a variety of additional thoracic malignancies that contribute to morbidity and mortality of the US population including mesothelioma and other pleural based cancers and thymoma. All of these thoracic malignancies pose unique challenges that have limited the effectiveness of current therapies, necessitating the development of new and innovative approaches.

Tumor treatment fields (TTF) have recently been established as a new and effective treatment for a variety of solid tumor malignancies. TTF provides a unique ability to deliver targeted and sustained therapy via an LCR meter. TTF has shown promise for some of the most aggressive malignancies such as glioblastoma and therefore should be considered for aggressive thoracic malignancies as well. In order to develop a TTF protocol that is both efficient and efficacious, the electric field properties of target tumors must be understood. Although well established for some tumors, the complete electric properties of thoracic malignancies as they apply to TTF is still not fully understood. The proposed project is to address this gap of knowledge.

Our plan is to analyze 3-5 tissue probes acquired from 30 patients with a variety of thoracic malignancies. Tissue will be acquired in the operating room and will be analyzed immediately. The investigators will plan to acquire tissue from each type of malignancy including: lung cancer, esophageal cancer and pleural based tumors. After acquisition of data, the investigators will assess the data and continue to acquire patients to obtain significant estimates of overall tissue properties in each type of tumor. The investigators will offer all patients at our center undergoing resection of thoracic malignancies the opportunity to participate in the study. After undergoing an informed consent process in accordance with IRB approval, patients with be formally enrolled. The LCR meter used for electric property analysis of the tissue will be positioned on and secured to a movable cart so that it can be brought to the operating room for rapid tissue analysis following surgical excision of the tumor. Impedance measurements will be collected on multiple sections of excised tissue and will be translated into dielectric properties. All tumor electric property data will be stored securely and remain anonymous of patient identifying data.

Dielectric Properties of Matched Tissue Samples From Thoracic Malignancies and Corresponding Normal Tissues

Determination of Dielectric Properties of Matched Tissue Samples From Thoracic Malignancies and Corresponding Normal Tissues

The following information will be recorded from all samples and provided to Novocure Ltd; 1) Type of tumor tissue 2) Measured electric properties 3) ID/ serial number connecting sample to annotated CT image

The impedance measurements in different frequencies will be collected on multiple sections of excised tissue and will be translated into dielectric properties. The conductivity and relative permittivity measurements in frequencies range (20Hz-1MHz) of tissues will be collected and analyzed.

NovoCure Ltd.

University of Maryland, Baltimore

Head, Division of Thoracic Surgery

Heart and Blood Diseases

Symptoms and General Pathology

Aortic Dissection

Dissection, Blood Vessel

Aneurysm

Vascular Diseases

Syndrome

Acute Aortic Syndrome

Aortic Diseases

Acute Graft Versus Host Disease

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunomodulating Agents

Immunoglobulins

IBI308 200mg intravenous drip every three weeks following adaptive radiation therapy.

A humanized anti-PD-1 monoclonal antibody

IBI308

Haihua Yang, MD

Yinnan Meng, MD

Fengming (Spring) Kong, MD

This phase II study is to evaluate the safety and efficacy of CT-based adaptive radiation therapy followed by adjuvant anti-PD-1 antibody immunotherapy in treating patients with different types and stages of thoracic malignancies. (CARTAI)

PRIMARY OBJECTIVES:

I. To evaluate the safety and toxicity of anti-programmed cell death 1 (PD-1) inhibition consolidation therapy after radiation therapy for multiple thoracic malignancies.

SECONDARY OBJECTIVES:

I. To assess the efficacy of adjuvant anti-PD-1 antibody immunotherapy after radiotherapy.

II. To understand the dynamics and interactions of IDO with others immune pathway biomarkers.

III. To evaluate whether IDO immune status could predict the treatment outcomes of radiation and immune combined therapy.

CT-Guided Adaptive Radiation Therapy Combine With Anti-PD-1 Antibody Adjuvant Immunotherapy for Thoracic Cancer Patients

A Safety and Efficacy Study of CT-Guided Adaptive Radiation Therapy With Anti-PD-1 Antibody Adjuvant Immunotherapy in Patients With Thoracic Cancer (CARTAI)

Number of participants with adverse events and serious adverse events at 6 months will be measured. \[CTCAE v4.03\]

Objective response rate is the percentage of patients with at least once occurrence of PR or CR \[RECIST v1.1\]

Duration of response is the time interval from first occurrence of PR or CR until PD or death \[RECIST v1.1\]

Number of patients with acute and chronic adverse events will be measured \[CTCAE v4.03\]

Progression-Free-Survival is the time interval from the start of treatment until disease progression or death by any cause \[RECIST v1.1\]

Overall Survival is the time interval from the start of treatment to death from any cause.

Taizhou Hospital

Head of Department of Radiation Oncology, Chief Physician

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Three 4D CT scans will be performed. After you are out of the CT scanner, ventilation images will be calculated from the 4D CT images and will be compared with the standard ventilation imaging method.

4D CT scans

Lung function imaging performed to provide information on how well the lungs work, how air moves into the lungs with breathing, and blood circulation into the lungs.

Lung Function Imaging

Heath Skinner, MD, PHD

Objectives:

Primary Objective:

1. To determine the correlation between 4-dimensional computed tomography (4D CT) derived ventilation and single photon emission tomography (SPECT) aerosol Tc-99m determined ventilation.

Secondary Objective:

1. To evaluate the reproducibility of the 4D CT derived ventilation and to obtain an estimate of the variance in a single setting.
2. To assess the correlation between hypoperfused and hypoventilated pulmonary regions in patients with thoracic malignancies.
3. To investigate the effect of continuous positive airway pressure (CPAP) on ventilation and tumor motion.

By using a 4-dimensional (4D) computed tomography (CT) scans researchers will create ventilation (circulation of air) calculations. This new calculation method is quicker and may produce better images than the standard ventilation calculations.

If you agree to take part in this study and are found to be eligible, you will have lung function imaging. Lung function imaging gives researchers information on how well the lungs work, how air moves into the lungs with breathing, and blood circulation into the lungs.

You will have three 4D CT scans performed while you are breathing quietly. A 2-inch plastic box will be placed on top of your chest to monitor the motion of your chest during the scanning. After you are out of the CT scanner (once the scanning is finished), ventilation images are calculated from the 4D CT images and will be compared with the standard ventilation imaging method. The 4D CT imaging will take about 30 minutes to complete.

As part of standard care, once you have finished the 4D CT scan, you will have a single photon emission computed tomography (SPECT) pulmonary (lung) ventilation scan performed. The SPECT ventilation scan requires that you first breathe in a radioactive aerosol (or mist, called Tc-99m DPTA), which will help the study doctor tell where air goes when you breathe. Then you will be placed in the SPECT scanner, and images will be taken of your lungs. The SPECT imaging will take about 1 hour to complete.

Within 10 days after the first imaging session, you will return for a second imaging session. During the second imaging session, you will have a standard of care SPECT pulmonary perfusion (blood supply to tissue and organs) test done. During this test, a radioactive substance is given by vein (called Tc-99m MAA). This substance will get trapped in the lungs, and the SPECT imaging will show the blood flow in the lungs. This test should take 45-60 minutes to complete.

Once you complete the second imaging session, your participation will over in this study.

This is an investigational study. All of the imaging scans used in this study are FDA approved and commercially available. The calculation of ventilation images from 4D CT scanning is investigational and authorized for use in research only. Up to 36 patients will take part in this study. All will be enrolled at M. D. Anderson.

4-Dimensional CT Derived Ventilation Versus SPECT Aerosol Ventilation in Patients With Thoracic Malignancies

Phase II Trial Comparing 4-Dimensional Computed Tomography Derived Ventilation Versus SPECT/CT Tc-99m Aerosol Ventilation in Patients With Thoracic Malignancies

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Blood and Lymph Conditions

Sarcoma

Thymoma

Thymus Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Neoplasms, Connective and Soft Tissue

Pleural Neoplasms

Lymphatic Diseases

Soft Tissue Sarcoma

Antineoplastic Agents

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Vaccines

Decitabine

Celecoxib

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase 2 Inhibitors

Cyclooxygenase Inhibitors

Enzyme Inhibitors

400 mg PO BID for 7 days prior to cell administration and then on days 1 through 28 of each vaccine cycle.

Celebrex

A minimum of 1x10e7 and a maximum of 1x10e8 patient tumor cells that have been exposed to 1 mcM decitabine for 6 days, exposed to 100 Gy radiation and emulsified in 0.5 ml of the ISCOMATRIX adjuvant at a concentration of 180 ISCO units/mL administered IM every 4 weeks for 6 injections; if subject shows immune response, vaccine will be given every three months from months 9 - 24

Tumor cell vaccine

David S Schrump, M.D.

Background:

- Recent research has shown that causing an immune response to tumor cells may help slow or stop the growth of tumors. One treatment that has come from this research involves collecting and modifying a cancer patient's tumor cells in the laboratory, then returning the cells to the patient as a vaccine to encourage the immune system to respond to them. Researchers are interested in testing tumor cell vaccines with an experimental drug called ISCOMATRIX , which can be added to a vaccine in order to elicit a stronger immune response in the body. ISCOMATRIX has not been approved for sale and use in any country and its use is still experimental, though it has been tested and used safely in other clinical studies. Researchers are also interested in determining whether the anti-inflammatory drug celecoxib will improve the body's immune reaction if given with the vaccine.

Objectives:

- To assess the safety and effectiveness of tumor cell vaccines given with ISCOMATRIX and celecoxib in the treatment of lung and esophagus cancers.

Eligibility:

* Individuals at least 18 years of age who have primary small cell or non-small cell lung cancer, esophageal cancer, or pleural mesothelioma that can be removed by surgery.
* Only individuals whose tumor cells are able to produce a tumor cell line for vaccine development will be eligible for treatment.

Design:

* Participants will be screened with a physical examination and medical history, and will have tumor tissue collected during their surgery to determine whether the tumor cells can be used to produce a vaccine.
* Participants will take celecoxib twice daily for 7 days before having the first tumor cell vaccination. Participants will also have leukapheresis to collect blood cells for testing before the first vaccination.
* Participants will receive one vaccine (which may be given in two shots) monthly for 6 months, and will continue to take celecoxib twice daily. One month after the 6th vaccine shot, participants will have another leukapheresis and skin test. If these tests show that a participant is responding to the vaccine, additional vaccines will be given every 3 months for up to 2 years.
* Participants will have a physical exam and lab tests before each vaccination, blood samples and imaging studies every 3 months, and a skin test every 6 months.
* Participants will have regular followup visits with imaging studies and blood samples for up to 5 years after the first vaccination, or until a new tumor develops.

Background:

* Cancer-testis (CT) antigens have emerged as attractive targets for cancer immunotherapy. Whereas lung and esophageal cancers, thymic Neoplasms, primary thoracic sarcomas, as well as malignant pleural mesotheliomas express a variety of CT antigens, primary or vaccine-induced immune responses to these antigens appear uncommon in patients with these malignancies, possibly due to low-level, heterogeneous antigen expression, and inadequate vaccination strategies.
* Because numerous CT antigens can be induced in tumor cells by DNA demethylating agents and HDAC inhibitors, it is conceivable that vaccination of cancer patients with autologous tumor cells exposed to chromatin remodeling agents will enhance anti-tumor immunity in these individuals.
* In order to examine this issue, patients with resectable primary neoplasms involving the lungs, esophagus, or pleura will be vaccinated with autologous tumor cells exposed exvivo to decitabine and radiation following completion of appropriate combined modality therapy. Vaccine will be administered in conjunction with ISCOMATRIX adjuvant and oral celecoxib.

Primary Objective:

- To assess the safety of an epigenetically modified autologous tumor cell vaccine in conjunction with celecoxib.

Eligibility:

* Patients with histologically or cytologically proven or clinically evident primary pulmonary carcinoma or sarcoma, esophageal cancer, thymic carcinoma or malignant pleural mesothelioma undergoing resection of their neoplasms.
* Patients must be 18 years or older with an ECOG performance status of 0 2, with adequate pulmonary and cardiac function and laboratory values within normal limits.

Design:

* Patients with operable lung and esophageal carcinoma/sarcoma, thymoma, thymic carcinoma or malignant pleural mesothelioma will undergo resection of their malignancies at the NCI.
* Portions of the resected tumors will be transferred to the Thoracic Oncology Laboratory and cells will be processed to establish a cancer cell line.
* Following recovery from surgery and appropriate adjuvant chemotherapy and/or radiation, patients will be vaccinated with epigenetically-modified autologous tumor cells periodically over 6 months in conjunction with oral celecoxib.
* Systemic toxicities and delayed type hypersensitivity responses to autologous tumor cells and serologic responses to a variety of CT antigens will be assessed before and after vaccination.
* Patients will be followed with routine staging scans until disease recurrence.
* As the exact set of comparisons and analyses to be performed will be determined following completion of the trial, and will be based on limited numbers of patients, the analyses will be considered exploratory and hypothesis generating rather than definitive.
* Approximately 120 patients will be accrued to this trial in order to obtain up to 30 evaluable patients.

Tumor Cell Vaccines With ISCOMATRIX Adjuvant and Celecoxib in Patients Undergoing Resection of Lung and Esophageal Cancers and Malignant Pleural Mesotheliomas

Epigenetically-Modified Autologous Tumor Cell Vaccines With ISCOMATRIX(TM) Adjuvant and Oral Celecoxib in Patients Undergoing Resection of Lung and Esophageal Cancers, Thymic Neoplasms, Thoracic Sarcomas, and Malignant Pleural Mesotheliomas

Mouth and Tooth Diseases

Stomatitis

Mucositis

Esophagitis

Gastroenteritis

Mouth Diseases

Stomatognathic Diseases

Anti-Infective Agents

Amino Acids

Sirolimus

Temsirolimus

MTOR Inhibitors

Glutamine

Participants receive placebo beginning on Day 1 of an mTOR inhibitor based therapy. Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy.

Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy.

Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times.

Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times.

mTOR Inhibitor Patient Group: Participants receive placebo beginning on Day 1 of an mTOR inhibitor based therapy. Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy.

Placebo

mTOR Inhibitor Patient Group - Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy.

Questionnaire completion for mTOR Inhibitor Patient Group: At baseline, Day 1 of cycle 2 and beyond, after 6 months of chemotherapy, and at end of study visit.

Questionnaires

Aung Naing, MD

The goal of this clinical research study is to learn if glutamine can help control and prevent sores, blisters, or inflammation in your mouth or esophagus due to your current treatment.

In this study, glutamine will be compared to a placebo. A placebo is not a drug. It looks like the drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

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 glutamine.
* If you are in Group 2, you will receive a placebo.

Neither you nor the study staff will know if you are receiving the study drug or the placebo. However, if needed for your safety, the study staff will be able to find out what you are receiving.

Study Drug Administration:

Glutamine or the placebo will be taken as a sugary drink by mouth. You will take the drink twice daily starting the day you first receive your anti-cancer therapy or radiation treatment.

You will mix one scoop of powder with 25-100 milliliters (about 2-6 tablespoons) of water. If you are in the chemotherapy group, you will swish the drink for 10 seconds and swallow. If you are in the radiation group, you will swallow the drink in small amounts several times.

Study Visits:

At every visit, you will be asked about any side effects you may be having and about any other drugs you may be taking.

Chemotherapy Group:

On Days 1, 8, and 22 of Cycle 1:

* You will have a mouth exam.
* Your weight will be recorded.

On Day 15 of Cycle 1:

* You will have a mouth exam.
* Your weight will be recorded.
* You will complete a quality of life questionnaire.

On Day 1 of Cycle 2 and beyond:

* You will have a mouth exam.
* Your weight will be recorded.
* If the doctor thinks it is needed, blood (about 2 teaspoons) will be drawn for routine tests.
* You will complete a quality of life questionnaire.
* You will complete a survey about how you feel about the study drug. This should take about 5-10 minutes to complete.
* If the doctor thinks it is needed, you will have a photograph of your mouth taken.

After 3 months of chemotherapy:

* You will complete a quality of life questionnaire.

After 6 months of chemotherapy:

* Your weight will be recorded.
* You will complete a quality of life questionnaire.

Follow-Up:

For your follow-up questionnaires at Day 1 of every Cycle, at 3 and 6 months, and during the End-of-Study visit, you may be called by the study team. This call should last about 5-10 minutes.

Radiation Therapy Group:

On Weeks 1, 2, 4, and 6 of Radiation:

* You will be asked if you have inflammation of your esophagus.
* Your weight will be recorded.
* If the doctor thinks it is needed, blood (about 2 teaspoons) will be drawn for routine tests.

On Weeks 3 and 5 of Radiation:

* You will be asked if you have inflammation of your esophagus.
* Your weight will be recorded.
* If the doctor thinks it is needed, blood (about 2 teaspoons) will be drawn for routine tests.
* You will complete a quality of life questionnaire.
* You will complete a survey about how you feel about the study drug.

On Week 7 of Radiation:

* You will be asked if you have inflammation of your esophagus.
* Your weight will be recorded.
* If the doctor thinks it is needed, blood (about 2 teaspoons) will be drawn for routine tests.
* You will complete a quality of life questionnaire.
* You will complete a survey about how you feel about the study drug.

  1 month after your radiation has ended:
* You will be asked if you have inflammation of your esophagus.
* Your weight will be recorded.
* If the doctor thinks it is needed, blood (about 2 teaspoons) will be drawn for routine tests.
* You will complete a quality of life questionnaire.
* You will complete a survey about how you feel about the study drug.

  3 months after your radiation has ended:
* You will complete a quality of life questionnaire.

Follow-Up:

For your follow-up questionnaires at 1 and 3 months and during the End-of-Study visit, you may be called by the study team. This call should last about 5-10 minutes.

Length of Study:

You may continue taking the study drug for as long as the doctor thinks it is in your best interest.

You will continue taking the glutamine or placebo for 4 weeks after the completion of your anti-cancer therapy or radiation treatment. If you stop chemotherapy or radiation before completion of the intended study period, you will continue to take the study drug for 4 weeks.

If you develop severe sores, blisters, or inflammation in your mouth or esophagus, you will be removed from the study, and the doctor will give you another medication for your sores and blisters.

Your participation on the study will be over 6 months after completion of your therapy.

End-of-Study Visit:

After you are off study, you will have an end-of-study visit. For the radiation group, this will be 6 months after radiation therapy. For the chemotherapy group, this is 4 weeks after the last dose.

* Your weight will be recorded.
* If the doctor thinks it is needed, blood (about 2 teaspoons) will be drawn for routine tests.
* You will complete a quality of life questionnaire.
* If you are in the chemotherapy group, you will have a mouth exam.

This is an investigational study. Glutamine is FDA approved and commercially available for the treatment of short bowel syndrome. Its use to treat mouth sores and inflammation of the esophagus is investigational.

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

Randomized Trial of Glutamine in Patients With Mucositis or Esophagitis

Randomized, Double Blinded Placebo-Controlled Study of Glutamine in Patients With Oral Mucositis on an mTOR Inhibitor-based Regimen or Esophagitis on a Regimen Receiving Radiation to the Esophagus

For esophagus radiation participants, the severity of esophagitis will be taken as the highest grade observed by week six. Wilcoxon rank sum test used to compare the ordered categories of esophagitis severity.

For mTOR inhibitor patients, the severity of oral mucositis will be taken as the maximum grade observed during the 6-month study period. Wilcoxon rank sum test used to compare the ordered categories of mucositis severity.

The Quality of Life assessed by the MD Anderson Symptom Inventory for head and neck cancer (MDASI-HN). The 13 Core symptoms include dry mouth, fatigue, pain, disturbed sleep, drowsiness, feeling of being distressed, anorexia, sadness, numbness/tingling, dyspnea, difficulty remembering, nausea, and vomiting. The 9 Head and Neck symptoms include mouth sores, problems with taste, constipation, teeth/gum problems, skin pain, difficulty with voice, choking/coughing, difficulty swallowing, and problems with mucus specific to head and neck cancers. Total symptom severity include 24 core and Head and Neck symptoms together. Symptom interference asks patients about how their symptoms impact their daily functions. The severity of each symptom and symptom interference is rated on a numerical scale from 0 (symptom is absent) to 10 (worst possible severity)." Higher scores indicate a greater symptom burden.

Participants in each arm received at least 60% of planned doses of the study drug (glutamine or placebo).

Proportion of participants who were free of Mucositis at 18.3 weeks..

Investigators recorded weight at baseline to the end of treatment with glutamine/placebo. Weight loss calculated at each study assessment visit using the Wilcoxon rank sum test.

Investigators recorded the weight at baseline and the end of the study. Weight loss calculated at each study assessment visit using the Wilcoxon rank sum test.

CTCAE version 4.03 used to access the adverse events. Grade 1 Asymptomatic; clinical or diagnostic observations only; intervention not indicated Grade 2 Symptomatic; altered eating/swallowing; oral supplements indicated Grade 3 Severely altered eating/swallowing; tube feeding, TPN or hospitalization indicated. Total toxicity-evaluable is the total number of participants who had at least one dose of glutamine or placebo.

CTCAE version 4.03 used to access the adverse events. Grade 1 Asymptomatic; clinical or diagnostic observations only; intervention not indicated Grade 2 Symptomatic; altered eating/swallowing; oral supplements indicated Grade 3 Severely altered eating/swallowing; tube feeding, TPN or hospitalization indicated. Total toxicity-evaluable is the total number of participants who had at least one dose of glutamine or placebo

Healios Oncology Nutrition

Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times.

Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.

Radiation Therapy to Esophagus Patient Group - Glutamine

Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times.

Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.

Radiation Therapy to Esophagus Patient Group - Placebo

Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy.

Questionnaires: Questionnaire completion for mTOR Inhibitor Patient Group: At baseline, Day 1 of cycle 2 and beyond, after 6 months of chemotherapy, and at end of study visit.

mTOR Inhibitor Patient Group - Glutamine

Participants receive placebo beginning on Day 1 of an mTOR inhibitor based therapy. Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy.

Questionnaires: Questionnaire completion for mTOR Inhibitor Patient Group: At baseline, Day 1 of cycle 2 and beyond, after 6 months of chemotherapy, and at end of study visit.

mTOR Inhibitor Patient Group - Placebo

Participants receive placebo beginning on Day 1 of an mTOR inhibitor based therapy. Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy.

Questionnaire completion for mTOR Inhibitor Patient Group: At baseline, Day 1 of cycle 2 and beyond, after 6 months of chemotherapy, and at end of study visit.

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Esophageal

Head & Neck

Lung

Endometrial cancer

Cancer Type

no data for BMI taken for the mTOR cohort

Data were unavailable for 1 participant who withdrew consent after randomization but before treatment start in mTOR Inhibitor Patient Group-Placebo

Aung Naing, MD-Professor, Invest. Cancer Therapeutics

Grade 1

Grade 2

Grade 3

Absent

Participants who took at least 60% of the planned doses of the study treatment and were evaluable per protocol definition.

Severity of Esophagitis for Radiation Therapy Patients

Evaluable Participants in the mTOR Inhibitor Cohort

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dielectric Properties of Matched Tissue Samples From Thoracic Malignancies and Corresponding Normal Tissues	NCT04804410	Lung Cancer Esophageal Canc... Mesothelioma; L...	LCR Meter (Bran...	-	University of Maryland, Baltimore
CT-Guided Adaptive Radiation Therapy Combine With Anti-PD-1 Antibody Adjuvant Immunotherapy for Thoracic Cancer Patients	NCT03732430	Thoracic Malign...	IBI308	18 Years - 75 Years	Taizhou Hospital
CT-Guided Adaptive Radiation Therapy Combine With Anti-PD-1 Antibody Adjuvant Immunotherapy for Thoracic Cancer Patients	NCT03732430	Thoracic Malign...	IBI308	18 Years - 75 Years	Taizhou Hospital
4-Dimensional CT Derived Ventilation Versus SPECT Aerosol Ventilation in Patients With Thoracic Malignancies	NCT00531180	Esophageal Canc... Lung Cancer	4D CT scans Lung Function I...	-	M.D. Anderson Cancer Center
Tumor Cell Vaccines With ISCOMATRIX Adjuvant and Celecoxib in Patients Undergoing Resection of Lung and Esophageal Cancers and Malignant Pleural Mesotheliomas	NCT01258868	Mesolthelioma Esophageal Canc... Lung Cancer Thoracic Sarcom... Thymoma	Celebrex Tumor cell vacc...	18 Years - 99 Years	National Institutes of Health Clinical Center (CC)
Randomized Trial of Glutamine in Patients With Mucositis or Esophagitis	NCT01952847	Advanced Cancer...	Placebo Glutamine Questionnaires	17 Years -	M.D. Anderson Cancer Center
4-Dimensional CT Derived Ventilation Versus SPECT Aerosol Ventilation in Patients With Thoracic Malignancies	NCT00531180	Esophageal Canc... Lung Cancer	4D CT scans Lung Function I...	-	M.D. Anderson Cancer Center
Radiotherapy-Associated Atrial Fibrillation	NCT05927246	Atrial Fibrilla...	ECG	18 Years - 99 Years	Istanbul University

Spots Global Cancer Trial Database for thoracic malignancies