Disease Outcomes and Toxicities in Patients With Gastrointestinal and Sarcomatous Malignancies
- Conditions
- Gastrointestinal CancerSarcoma
- Interventions
- Other: SurveyOther: Toxicity Assessments
- Registration Number
- NCT05743426
- Lead Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Single Arm Survey Subjects who are with gastrointestinal malignancies or sarcoma receive radiotherapy. Single Arm Toxicity Assessments Subjects who are with gastrointestinal malignancies or sarcoma receive radiotherapy.
- Primary Outcome Measures
Name Time Method Disease-free survival Up to 10 years Disease-free survival is defined as the length of time after treatment in which the subject survives with no signs or symptoms of cancer.
- Secondary Outcome Measures
Name Time Method Quality of life Toronto Extremity Salvage Score (TESS) Up to 10 years 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.Quality of life PRO-CTCAE Up to 10 years 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).Local Control Up to 10 years Local Control is defined as radiographic and clinical assessments determined by the patient's treating physician.
Adverse Events Up to 10 years 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.
Quality of life EQ-5D-5L Up to 10 years 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.
Trial Locations
- Locations (1)
University of North Carolina at Chapel Hill, Department of Radiation Oncology
🇺🇸Chapel Hill, North Carolina, United States