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RecruitingObservational

Disease Outcomes and Toxicities in Patients With Gastrointestinal and Sarcomatous Malignancies

NCT ID: NCT05743426Sponsor: UNC Lineberger Comprehensive Cancer CenterLast updated: 2026-03-30

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.

Arms & interventions

  • OtherSurvey

    Patient Reported Outcome (PRO) questionnaire

  • OtherToxicity Assessments

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

Outcome measures

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.

    Time frame: Up to 10 years

Secondary

  • Local Control

    Time frame: Up to 10 years

  • Adverse Events

    Time frame: Up to 10 years

  • Quality of life PRO-CTCAE

    Time frame: Up to 10 years

  • Quality of life EQ-5D-5L

    Time frame: Up to 10 years

  • Quality of life Toronto Extremity Salvage Score (TESS)

    Time frame: Up to 10 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (1)

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

Chapel Hill, North Carolina, 27599

Recruiting
Victoria Xu · Contact
984-974-8744victoria_xu@med.unc.edu
Theodore K Yanagihara, MD · Principal Investigator