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NCT Number: NCT05743426

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.

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Key information

Conditions

Sarcoma Digestive System Diseases Digestive System Neoplasms Gastrointestinal Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of North Carolina at Chapel Hill, Department of Radiation Oncology

Chapel Hill, North Carolina, 27599, United States

Location status: Recruiting

Location contact

Theodore K Yanagihara, MD

PRINCIPAL_INVESTIGATOR

Victoria Xu

CONTACT

[email protected]

984-974-8744

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Survey

Other

Patient Reported Outcome (PRO) questionnaire

Toxicity Assessments

Other

Toxicity Assessments will be performed using the National Cancer Institute Common Terminology Criteria (NCI-CTCAE).

Primary outcomes

  1. Disease-free survival

    Time frame: 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 outcomes

  1. Local Control

    Time frame: Up to 10 years

    Local Control is defined as radiographic and clinical assessments determined by the patient's treating physician.

  2. Adverse Events

    Time frame: 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.

  3. Quality of life PRO-CTCAE

    Time frame: 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).

  4. Quality of life EQ-5D-5L

    Time frame: 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.

  5. Quality of life Toronto Extremity Salvage Score (TESS)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Olivia Roberts

CONTACT

[email protected]

Victoria Xu, MD, PhD

CONTACT

[email protected]

+1 984-974-8744

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Registry information

Important dates

Study start
2023
Primary completion
2036
Study completion
2036
First posted
Feb 24, 2023
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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