Disease Outcomes and Toxicities in Patients With Gastrointestinal and Sarcomatous Malignancies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Survey, Toxicity Assessments.
- Who it may be relevant to
- Registry conditions: Sarcoma, Gastrointestinal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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]
Secondary outcome measures (5)
- 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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of North Carolina at Chapel Hill, Department of Radiation Oncology — Chapel Hill
Identifiers
NCT: NCT05743426 · LCCC2247