RECRUITINGOBSERVATIONAL
Disease Outcomes and Toxicities in Patients With Gastrointestinal and Sarcomatous Malignancies
About This Trial
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.
Who May Be Eligible (Plain English)
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 willing to sign a consent form 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 willing to sign a consent form
2. Patients who state they do not expect to be available or willing to follow up at expected intervals post-treatment
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
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).
Locations (1)
University of North Carolina at Chapel Hill, Department of Radiation Oncology
Chapel Hill, North Carolina, United States