Neuroendocrine Tumors

Liver Metastases

Single-photon emission computed tomography (SPECT) imaging will assess 99mTc-MAA (MAA being macro aggregated albumin) deposition in the tumour bed to estimate the dose of radiation to tumour and healthy tissue, before administration of TheraSpheres to eligible patients

TheraSpheres Selective Internal Radiation Therapy (SIRT)

Imperial College NHS Trust

TheraSphere Selective Internal Radiation Therapy (SIRT) as Treatment for Neuroendocrine Tumours With Liver Mets

A Phase II Assessment of the Safety and Efficacy of TheraSphere® Selective Internal Radiation Therapy (SIRT) in the Treatment of Metastatic (Liver) Neuroendocrine Tumours (NETs)

Record incidence of adverse events overall and by severity, as well as serious adverse events using the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) for Adverse Events, version 4.03 (CTCAE V4.03)

This is the best overall response (CR+PR) determined by RECIST 1.1

Determined by RECIST 1.1 and defined as date of treatment to the date of first documentation of disease progression

Date of randomisation to the date of death from any cause, or censored at date of last contact

Evaluated using the European Organisation for Research and Treatment of Cancer (EORTC) questionnaires QLQ-C30 (Quality of Life Questionnaire type C30) at baseline, week 8 and 3 monthly thereafter

- Evaluated using the European Organisation for Research and Treatment of Cancer (EORTC) questionnaires QLQ-I.NET21 (Quality of Life Questionnaire, type I.Neuroendocrine Tumour number 21) at baseline, week 8 and 3 monthly thereafter

Patients will have a liver CT scan at baseline, 12 weeks post SIRT, 3 monthly thereafter and at disease progression - results will be compared to patient clinical data

Blood samples will be collected at screening, week 8, week 12 and at disease progression for ctDNA analysis

Imperial College London

Biocompatibles UK Ltd, a BT International group company

The program comprises the practice of resistance exercises for the main muscular groups, with free weights and with their own body weight against the action of gravity, the proposal consists of 3 weekly sessions, for 8 consecutive weeks.

Acromegaly

Muscle Dysfunction

Physical Activity

Exercise

Activities included overall stretching and strengthening (flexion, extension, adduction and abduction movements) and muscular endurance exercises (exercises involving open and closed kinetic chains), along with aerobic conditioning using a functional circuit.

Physical activity

Centro universitário augusto motta

Rehabilitation Program in Patients With Acromegaly

Impact of a Physical Rehabilitation Program on the Quality of Life of Patients With Acromegaly: a Non-randomized Clinical Trial.

Peripheral muscle strength and fatigue strength will be evaluated using an EMG -810 surface electromyograph and a DIN_TRO traction dynamometer. For the strength test, the muscle evaluated will be the femoral quadriceps, the patient will be instructed to perform the knee extension, with the highest possible isometric force. Your positioning will be seated with your hands crossed over the chest, with the upright trunk adjusted by the backrest in order to allow the angle of 90 ° for hip flexion. For analysis of fatigue strength, surface electromyography of the medial vastus muscle (VM) of the dominant lower limb will be used through the 8-channel surface electromyograph from the gross signal. The endurance test consists of a contraction sustained for 60 seconds using 50% of the highest MIVM obtained in the strength test.

For the execution of the TC6M, the patient will be previously oriented to use sneakers and comfortable clothing. Later it will be positioned in a corridor of 30 meters, demarcated every 3 meters and oriented to walk as fast as possible, but without running, for a total period of 6 minutes. Peripheral saturation of O2 (SpO2), heart rate (HR), modified Borg scale, blood pressure (BP) during the test will be checked. There will be two tests with a 30 minute interval between them. The distance selected will be the patient's best performance. This is based on reducing the learning effect. Subsequently, the data found will be associated with the forecast of Britto et al. (2013) according to age, height and body weight of each individual.

The Acromegaly Quality of Life Questionnaire (AcroQol) is a specific, simple and valid instrument for assessing quality of life in people suffering from acromegaly aged 18-70 years. It can be used in two different fields: in clinical trials of new drugs as well as in the follow-up of patients in clinical practice. This is particularly useful in evaluating the effects of intervention or treatment. The questionnaire is one-dimensional and contains 22 items divided into two scales: one that evaluates physical aspects (eight items) and another that evaluates the psychological aspects (14 items). The latter is also divided into two sub-scales: one evaluates physical appearance and another evaluates the impact of the disease on the patient's personal relationships (seven items each). The score is given from 1 to 5 where, the lower the score, the worse the quality of life.

The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale was developed for individuals with chronic diseases to evaluate health-related quality of life, treating fatigue as a multidimensional concept. This scale has been applied in different groups of patients with different types of dysfunctions. FACIT-F is a specific scale of evaluation of fatigue that has good representation of the individual's frame, considered as an instrument of easy application, and its use authorized by the author of the same. It will be answered by the researcher himself, with 13 questions ranging from 0 to 4, where the higher the score, the less fatigue. Your score goes from 0 to 52.

The Lower Extremity Functional Scale (LEFS) is a self-administered questionnaire for orthopedic assessment of lower limb integrity. It was developed according to the concepts of functionality and disability of the World Health Organization (WHO). This scale comprises 20 questions and each has a score that varies between the minimum of zero (extremely difficult) and the maximum of four points (without difficulty). The sum of all items can generate a maximum total of 80 points. Such a level of punctuation suggests a normal functional state, that is, the higher the value obtained, the higher the level of functionality of the individual. The LEFS scale is easy to apply and can be used at different levels of functionality and disability related to the lower limbs. It is usually used in initial evaluations, during treatment and thereafter, in order to establish new therapeutic goals for patients.

Body weight and height of patients will be measured using a Filizola® mechanical scale with a maximum capacity of 150 kilograms and a sensitivity of 100 grams and a stadiometer. Body mass index (BMI) will be calculated by dividing body mass by height squared.

Evaluates the perception of the degree of effort, performed during the exercise. Currently, it is used in the modified form described with a score varying with scores between 0 where the level of perception of dyspnea (fatigue) or muscle fatigue is "none" until 10 where the level of perception of dyspnea (fatigue) or muscle fatigue is " maximum".

Data available in scientific environment.

Centro Universitário Augusto Motta

Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

After a physical therapy evaluation, the patient underwent a booklet-guided physical exercise program that lasted two months (3 times per week with a duration of 60 minutes per session). Activities included overall stretching and strengthening (flexion, extension, adduction and abduction movements) and muscular endurance exercises (exercises involving open and closed kinetic chains), along with aerobic conditioning using a functional circuit. The patient was evaluated at 3 different timepoints (baseline, after 8 weeks of training, and after a 4-week washout period with no treatment); thus, he served as his own control. The physiotherapist contacted the patient by phone weekly to follow the progression of the treatment. Throughout the application of the protocol, the patient regularly maintained his follow-up visits with the multidisciplinary team. Moreover, there was no change in pharmacological treatment throughout this period.

Patients receive cabozantinib S-malate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients receive placebo PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Atypical Carcinoid Tumor

Carcinoid Tumor

Digestive System Neuroendocrine Neoplasm

Functioning Pancreatic Neuroendocrine Tumor

Intermediate Grade Lung Neuroendocrine Neoplasm

Low Grade Lung Neuroendocrine Neoplasm

Lung Atypical Carcinoid Tumor

Lung Carcinoid Tumor

Metastatic Digestive System Neuroendocrine Tumor G1

Neuroendocrine Neoplasm

Non-Functioning Pancreatic Neuroendocrine Tumor

Pancreatic Neuroendocrine Tumor

Pancreatic Serotonin-Producing Neuroendocrine Tumor

Stage IIIA Digestive System Neuroendocrine Tumor AJCC v7

Stage IIIB Digestive System Neuroendocrine Tumor AJCC v7

Stage IV Digestive System Neuroendocrine Tumor AJCC v7

Cabozantinib S-malate

Laboratory Biomarker Analysis

Placebo Administration

Quality-of-Life Assessment

Katmai Oncology Group

Kingman Regional Medical Center

University of Arkansas for Medical Sciences

Kaiser Permanente-Deer Valley Medical Center

PCR Oncology

Sutter Auburn Faith Hospital

Alta Bates Summit Medical Center-Herrick Campus

Mills-Peninsula Medical Center

City of Hope Comprehensive Cancer Center

Epic Care-Dublin

Epic Care Partners in Cancer Care

Kaiser Permanente-Fremont

Palo Alto Medical Foundation-Fremont

Kaiser Permanente-Fresno

Contra Costa Regional Medical Center

Fremont - Rideout Cancer Center

Memorial Medical Center

Kaiser Permanente-Modesto

Palo Alto Medical Foundation-Camino Division

Alta Bates Summit Medical Center - Summit Campus

Kaiser Permanente-Oakland

Palo Alto Medical Foundation Health Care

Stanford Cancer Institute Palo Alto

Kaiser Permanente-Redwood City

Kaiser Permanente-Richmond

Kaiser Permanente-Roseville

Sutter Roseville Medical Center

Kaiser Permanente Downtown Commons

Sutter Medical Center Sacramento

University of California Davis Comprehensive Cancer Center

Kaiser Permanente-South Sacramento

California Pacific Medical Center-Pacific Campus

Kaiser Permanente-San Francisco

UCSF Medical Center-Mission Bay

Kaiser Permanente-Santa Teresa-San Jose

Kaiser Permanente San Leandro

Kaiser Permanente-San Rafael

Kaiser San Rafael-Gallinas

Kaiser Permanente Medical Center - Santa Clara

Palo Alto Medical Foundation-Santa Cruz

Kaiser Permanente-Santa Rosa

Kaiser Permanente-South San Francisco

Kaiser Permanente-Stockton

Palo Alto Medical Foundation-Sunnyvale

Kaiser Permanente Medical Center-Vacaville

Kaiser Permanente-Vallejo

Sutter Solano Medical Center/Cancer Center

Kaiser Permanente-Walnut Creek

Rocky Mountain Cancer Centers-Aurora

Rocky Mountain Cancer Centers-Boulder

Penrose-Saint Francis Healthcare

National Jewish Health-Main Campus

Rocky Mountain Cancer Centers-Midtown

SCL Health Saint Joseph Hospital

Rocky Mountain Cancer Centers-Rose

Mountain Blue Cancer Care Center - Swedish

Swedish Medical Center

National Jewish Health-Western Hematology Oncology

Saint Mary's Hospital and Regional Medical Center

North Colorado Medical Center

Good Samaritan Medical Center

Rocky Mountain Cancer Centers-Littleton

Rocky Mountain Cancer Centers-Sky Ridge

McKee Medical Center

National Jewish Health-Northern Hematology Oncology

SCL Health Lutheran Medical Center

MedStar Georgetown University Hospital

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Moffitt Cancer Center

Hawaii Cancer Care - Savio

Pali Momi Medical Center

Hawaii Cancer Care Inc-POB II

Queen's Cancer Cenrer - POB I

Queen's Medical Center

Straub Clinic and Hospital

Queen's Cancer Center - Kuakini

Kaiser Permanente Moanalua Medical Center

Saint Alphonsus Cancer Care Center-Boise

Saint Luke's Mountain States Tumor Institute

Saint Alphonsus Cancer Care Center-Caldwell

Kootenai Medical Center

Walter Knox Memorial Hospital

Saint Luke's Mountain States Tumor Institute - Fruitland

Idaho Urologic Institute-Meridian

Saint Luke's Mountain States Tumor Institute - Meridian

Saint Alphonsus Medical Center-Nampa

Saint Luke's Mountain States Tumor Institute - Nampa

Kootenai Cancer Center

Kootenai Cancer Clinic

Saint Luke's Mountain States Tumor Institute-Twin Falls

Illinois CancerCare-Bloomington

Illinois CancerCare-Canton

Illinois CancerCare-Carthage

University of Chicago Comprehensive Cancer Center

Carle on Vermilion

Cancer Care Specialists of Illinois - Decatur

Illinois CancerCare-Dixon

Carle Physician Group-Effingham

Crossroads Cancer Center

Illinois CancerCare-Eureka

Cabozantinib S-malate in Treating Patients With Neuroendocrine Tumors Previously Treated With Everolimus That Are Locally Advanced, Metastatic, or Cannot Be Removed by Surgery

Randomized, Double-Blinded Phase III Study of CABozantinib Versus Placebo IN Patients With Advanced NEuroendocrine Tumors After Progression on Everolimus (CABINET)

Will be assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 determined by retrospective independent central review. Will be compared between treatment arms using the stratified log rank test at one-sided level 0.025. The stratification factors will be used for the analysis. The hazard ratio (HR) for PFS will be estimated using a stratified Cox proportional hazards model, and the 95% confidence interval (CI) for the HR will be provided. Results from an unstratified analysis will also be provided. Kaplan-Meier methodology will be used to estimate the median PFS for each treatment arm, and Kaplan-Meier curves will be produced. Brookmeyer Crowley methodology will be used to construct the 95% CI for the median PFS for each treatment arm.

The analyses for OS will follow intent-to-treat (ITT) principle and will be conducted separately within each cohort (pancreatic neuroendocrine tumor [NET] and carcinoid tumor). The distribution of OS will be estimated using the method of Kaplan-Meier. The median OS, along with the 95% CI, will be estimated by the two treatment groups. Overall survival will be compared between treatment arms using the stratified log-rank test at a one-sided cumulative 2.5% level of significance. The stratified Cox regression will be used to estimate the HR of OS, along with the 95% CI. A hierarchical approach will be used to control for family-wise type-I error rate, therefore OS will be formally statistically tested only if the primary efficacy endpoint, PFS, is statistically significantly different between the two treatment groups.

For CTCAE data, the frequency tables will be reviewed to determine the patterns. The overall adverse event rates will be compared between treatment groups using Chi-square test (or Fisher's exact test if the data in contingency table is sparse). PRO-CTCAE data will, at minimum, be analyzed similarly to CTCAE data. The initial analysis of each PRO-CTCAE item will use all available scores in an analysis which mirrors the approach used for the CTCAE data. Supplemental analysis will use model-based multiple imputation incorporating baseline patient characteristics and physician-rated performance status. CTCAE data may be incorporated as auxiliary data into multiple imputation models for AEs which are captured by both PRO-CTCAE and CTCAE. Results from supplemental analysis will be descriptively compared to the results of the initial analysis to assess the robustness of results to missing data. Additional analyses of PRO-CTCAE data beyond those specified above may be undertaken.

Will be defined as the proportion of patients in each arm whose best response is either complete response (CR) or partial response (PR). Radiographic response rate for both cohorts: the analyses for radiographic response rate will follow the ITT principle and will be conducted separately within each cohort (pancreatic NET and carcinoid tumor). The proportion of patients with either CR or PR as their best response will be estimated using point estimates and 95% confidence intervals according to the methods in Duffy and Santner. Radiographic response rate will be compared between treatment arms using the 2-sample z-test to compare sample proportion at a one-sided 2.5% level of significance.

National Cancer Institute (NCI)