Disease Outcomes and Toxicities in Patients With Gastrointestinal and Sarcomatous Malignancies

Sarcoma Clinical Trial

Official title:

Disease Outcomes and Toxicities in Patients With Gastrointestinal and Sarcomatous Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05743426
• Other study ID #: LCCC2247
• Status: Recruiting
• Start date: March 17, 2023
• Est. completion date: January 1, 2036

Study information

• Verified date: March 2024
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: Victoria Xu, MD, PhD
• Phone: +1 984-974-8744
• Email: victoria_xu[@]med.unc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: January 1, 2036
• Est. primary completion date: January 1, 2036
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Sarcoma

Intervention

Other:
• Survey
Patient Reported Outcome (PRO) questionnaire
• Toxicity Assessments
Toxicity Assessments will be performed using the National Cancer Institute Common Terminology Criteria (NCI-CTCAE).

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill, Department of Radiation Oncology	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Local Control	Local Control is defined as radiographic and clinical assessments determined by the patient's treating physician.	Up to 10 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials