Recruiting

Observational Study

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT05743426

Conditions

Sarcoma

Gastrointestinal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Survey

Toxicity Assessments

Study Details

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.

Conditions

Sarcoma

Gastrointestinal Cancer

Study ID

NCT05743426

Start date

Mar 17, 2023

Status verified date

Mar, 2026

Completion date

Jan 1, 2036

Anticipated

Primary completion date

Jan 1, 2036

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

180 participants

Anticipated

Interventions and Outcome Measures

Arms

Single Arm

Subjects who are with gastrointestinal malignancies or sarcoma receive radiotherapy.

Interventions

Survey

Patient Reported Outcome (PRO) questionnaire

Toxicity Assessments

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

Primary outcome measure

  • Disease-free survival [ Time Frame: Up to 10 years ]

Central Contacts and Locations

Central contacts

Victoria Xu, MD, PhD

+1 984-974-8744victoria_xu@med.unc.edu

Olivia Roberts

olivia_roberts@med.unc.edu

Locations

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

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Victoria Xu

984-974-8744victoria_xu@med.unc.edu

Principal Investigator:

Theodore K Yanagihara, MD

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Keywords

  • toxicity
  • survey

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-03-30.