Disease Outcomes and Toxicities in Patients With Gastrointestinal and Sarcomatous Malignancies

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.

Study Overview

• Status: Recruiting
• Conditions: Sarcoma; Gastrointestinal Cancer
• Intervention / Treatment: Other: Survey; Other: Toxicity Assessments

• Study Type: Observational
• Enrollment (Estimated): 180

Contacts and Locations

• Study Contact: Name: Victoria Xu, MD, PhD; Phone Number: +1 984-974-8744; Email: victoria_xu@med.unc.edu
• Study Contact Backup: Name: Olivia Roberts; Email: olivia_roberts@med.unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • University of North Carolina at Chapel Hill, Department of Radiation Oncology
      • Principal Investigator: Theodore K Yanagihara, MD
      • Contact: Victoria Xu; Phone Number: 984-974-8744; Email: victoria_xu@med.unc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects with gastrointestinal malignancy or sarcoma receiving treatment at study center.

Description

Inclusion Criteria

In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

1. 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.
2. Age ≥ 18 years at the time of consent.
3. Histological, cytological, or radiographic evidence/confirmation of a gastrointestinal malignancy or sarcoma.
4. 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.

1. Inability or unwillingness to provide informed consent
2. Patients who state they do not expect to be available or willing to follow up at expected intervals post-treatment

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Investigators: Principal Investigator: Theodore K Yanagihara, Lineberger Comprehensive Cancer Center, The University of North Carolina Chapel Hill

Publications and helpful links

Helpful Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2023
• Primary Completion (Estimated): January 1, 2036
• Study Completion (Estimated): January 1, 2036

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: February 23, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: survey; toxicity
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Gastrointestinal Neoplasms
• Other Study ID Numbers: LCCC2247

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No