NCT05743426 · UNC Lineberger Comprehensive Cancer Center
Disease Outcomes and Toxicities in Patients With Gastrointestinal and Sarcomatous Malignancies
What this study is about
This forward-looking, 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.
View original scientific description
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.
Interventions
OTHER
Survey
Patient Reported Outcome (PRO) questionnaire
OTHER
Toxicity Assessments
Toxicity Assessments will be performed using the National Cancer Institute Common Terminology Criteria (NCI-CTCAE).
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Chapel Hill, North Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 30, 2026 · Source of record for eligibility and locations