Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Subjects who are with gastrointestinal malignancies or sarcoma receive radiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Survey | Other | Patient Reported Outcome (PRO) questionnaire |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Local Control | Local Control is defined as radiographic and clinical assessments determined by the patient's treating physician. | Up to 10 years |
| Adverse Events | The NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5 is a descriptive terminology that can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. |
Not provided
Inclusion Criteria
In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
Exclusion Criteria
All subjects meeting any exclusion criteria at baseline will be excluded from study participation.
Not provided
Not provided
Not provided
Subjects with gastrointestinal malignancy or sarcoma receiving treatment at study center.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Victoria Xu, MD, PhD | Contact | +1 984-974-8744 | victoria_xu@med.unc.edu | |
| Olivia Roberts | Contact | olivia_roberts@med.unc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Theodore K Yanagihara | Lineberger Comprehensive Cancer Center, The University of North Carolina Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill, Department of Radiation Oncology | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
Not provided
| Label | URL |
|---|---|
| University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
Not provided
Not provided
Not provided
Not provided
Not provided
| Toxicity Assessments |
| Other |
Toxicity Assessments will be performed using the National Cancer Institute Common Terminology Criteria (NCI-CTCAE). |
|
| Up to 10 years |
| Quality of life PRO-CTCAE | Quality of life PRO-CTCAE will be evaluated using patient-reported quality of life The PRO-CTCAE is a measurement system that characterizes the frequency, severity, interference, and presence/absence of symptomatic toxicities that include pain, fatigue, nausea, and cutaneous side effects such as rash and hand-foot syndrome, all toxicities that can be meaningfully reported from the patient's perspective. PRO-CTCAE responses are scored from 0 to 4 (or 0/1 for absent/present). | Up to 10 years |
| Quality of life EQ-5D-5L | Quality of life EQ-5D-5L will be evaluated using EQ-5D-5L. The EQ-5D-5L is a QoL assessment that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels ranging from no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5) to extreme problems. | Up to 10 years |
| Quality of life Toronto Extremity Salvage Score (TESS) | Toronto Extremity Salvage Score (TESS) quality of life questionnaire will be used in subjects with sarcoma. The TESS is a 30-item patient-reported outcome questionnaire that addresses daily activity limitations including restrictions in body movement, mobility, self-care, and performance of daily tasks. It is scored from 0 (not possible) to 5 (without any problem). Higher scores indicate less functional limitation. | Up to 10 years |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |