Disease Outcomes and Toxicities in Patients With Gastrointestinal and Sarcomatous Malignancies

UNC Lineberger Comprehensive Cancer Center

Status: Enrolling

Conditions: Sarcoma; Gastrointestinal Cancer

Treatments: Other: Survey; Other: Toxicity Assessments

Study type: Observational

Funder types: Other

Identifiers

NCT05743426

LCCC2247

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

180 participants in 1 patient group

Single Arm

Description:

Subjects who are with gastrointestinal malignancies or sarcoma receive radiotherapy.

Treatment:

Other: Toxicity Assessments

Other: Survey