Disease Outcomes and Toxicities in Patients With Gastrointestinal and Sarcomatous Malignancies

NCT05743426 | Recruiting DMC

• 1 other identifier: LCCC2247
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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

Keywords

toxicity; survey

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Local Control

  Up to 10 years

• Adverse Events

  Up to 10 years

• Quality of life PRO-CTCAE

  Up to 10 years

• Quality of life EQ-5D-5L

  Up to 10 years

• Quality of life Toronto Extremity Salvage Score (TESS)

  Up to 10 years

Study Arms (1)

Single Arm

Subjects who are with gastrointestinal malignancies or sarcoma receive radiotherapy.

Other: Survey; Other: Toxicity Assessments

Interventions

Survey OTHER

Patient Reported Outcome (PRO) questionnaire

Single Arm

Toxicity Assessments OTHER

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

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

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

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Sarcoma; Gastrointestinal Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Theodore K Yanagihara

  Lineberger Comprehensive Cancer Center, The University of North Carolina Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria Xu, MD, PhD

CONTACT

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

Olivia Roberts

CONTACT

olivia_roberts@med.unc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: February 24, 2023
• Study Start: March 17, 2023
• Primary Completion (Estimated): January 1, 2036
• Study Completion (Estimated): January 1, 2036
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)