Disease Outcomes and Toxicities in Patients With Gastrointestinal and Sarcomatous Malignancies

Study Overview
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Brief Summary
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This prospective, single-institution, observational study explores disease outcomes and toxicities in subjects with gastrointestinal malignancies and sarcoma (bone and soft tissue) who are being treated with standard-of-care therapies including radiotherapy. Recent advances in treatment approaches affected disease outcomes and toxicities. Prospective monitoring of disease outcomes and toxicities using standardized assessments will provide information about recent changes in the standard of care and further refine treatment approaches and prospective clinical trial design.

Official Title
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Disease Outcomes and Toxicities in Patients With Gastrointestinal and Sarcomatous Malignancies

Conditions
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Sarcoma, Gastrointestinal Cancer

Intervention / Treatment
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* Other: Survey
* Other: Toxicity Assessments


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria In order to participate in this study a subject must meet all of the eligibility criteria outlined below. Subject is willing and able to provide written informed consent to participate in the study and HIPAA authorization for the release of personal health information. Subjects are willing and able to comply with study procedures based on the judgment of the investigator or protocol designer. Age ≥ 18 years at the time of consent. Histological, cytological, or radiographic evidence/confirmation of a gastrointestinal malignancy or sarcoma. Females with childbearing potential and male subjects with fathering potential are allowed to participate in this study. Exclusion Criteria All subjects meeting any exclusion criteria at baseline will be excluded from study participation. Inability or unwillingness to provide informed consent Patients who state they do not expect to be available or willing to follow up at expected intervals post-treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single Arm<br>Subjects who are with gastrointestinal malignancies or sarcoma receive radiotherapy. | Other: Survey<br>* Patient Reported Outcome (PRO) questionnaire<br>Other: Toxicity Assessments<br>* Toxicity Assessments will be performed using the National Cancer Institute Common Terminology Criteria (NCI-CTCAE).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival | Disease-free survival is defined as the length of time after treatment in which the subject survives with no signs or symptoms of cancer. | Up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Control | Local Control is defined as radiographic and clinical assessments determined by the patient's treating physician. | Up to 10 years | 
| Adverse Events | The NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5 is a descriptive terminology that can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (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. Grade 5 Death related to AE. | Up to 10 years | 
| Quality of life PRO-CTCAE | Quality of life PRO-CTCAE will be evaluated using patient-reported quality of life The PRO-CTCAE is a measurement system that characterizes the frequency, severity, interference, and presence/absence of symptomatic toxicities that include pain, fatigue, nausea, and cutaneous side effects such as rash and hand-foot syndrome, all toxicities that can be meaningfully reported from the patient's perspective. PRO-CTCAE responses are scored from 0 to 4 (or 0/1 for absent/present). | Up to 10 years | 
| Quality of life EQ-5D-5L | Quality of life EQ-5D-5L will be evaluated using EQ-5D-5L. The EQ-5D-5L is a QoL assessment that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels ranging from no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5) to extreme problems. | Up to 10 years | 
| Quality of life Toronto Extremity Salvage Score (TESS) | Toronto Extremity Salvage Score (TESS) quality of life questionnaire will be used in subjects with sarcoma. The TESS is a 30-item patient-reported outcome questionnaire that addresses daily activity limitations including restrictions in body movement, mobility, self-care, and performance of daily tasks. It is scored from 0 (not possible) to 5 (without any problem). Higher scores indicate less functional limitation. | Up to 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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toxicity, survey