Disease Outcomes and Toxicities in Patients With Gastrointestinal and Sarcomatous Malignancies
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUNC Lineberger Comprehensive Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
Subjects with gastrointestinal malignancy or sarcoma receiving treatment at study center.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Survey
Other interventionPatient Reported Outcome (PRO) questionnaire
Toxicity Assessments
Other interventionToxicity Assessments will be performed using the National Cancer Institute Common Terminology Criteria (NCI-CTCAE).
Treatment groups
180 Participants
are divided into 1 treatment groupGroup A: Single Arm2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 10 yearsSecondary outcomes
1
Local Control
Local Control is defined as radiographic and clinical assessments determined by the patient's treating physician.
Time frame
Up to 10 years2
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.
Time frame
Up to 10 years3
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).
Time frame
Up to 10 years4
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.
Time frame
Up to 10 yearsSponsors and contacts
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Source ClinicalTrials.gov