SarcomaNCT05743426
Disease Outcomes and Toxicities in Patients With Gastrointestinal and Sarcomatous Malignancies
An observational study of Sarcoma and Gastrointestinal Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma, Gastrointestinal Cancer
- What is being tested?
- Survey and Toxicity Assessments
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2023to 1 Jan 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with gastrointestinal malignancy or sarcoma receiving treatment at study center.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Olivia Roberts contact
United States1 site, 1 recruiting
- Recruiting
University of North Carolina at Chapel Hill, Department of Radiation Oncology
Chapel Hill, North Carolina, 27599
Victoria Xu, 984-974-8744, victoria_xu@med.unc.edu
Theodore K Yanagihara, MD
About this study
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.
- Conditions
- Sarcoma, Gastrointestinal Cancer
- Being tested
- Survey, Toxicity Assessments
- Keywords
- toxicity, survey
- Medical subject headings
- Sarcoma, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Patient Reported Outcome (PRO) questionnaire
Toxicity AssessmentsOther
Toxicity Assessments will be performed using the National Cancer Institute Common Terminology Criteria (NCI-CTCAE).
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Subjects who are with gastrointestinal malignancies or sarcoma receive radiotherapy. Receives: Other: Survey; Other: Toxicity Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 10 years
Secondary outcomes (5)
Local Control
Local Control is defined as radiographic and clinical assessments determined by the patient's treating physician.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start17 Mar 2023
- Primary completion1 Jan 2036 (estimated)
- Study completion1 Jan 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Theodore K Yanagihara, Principal investigator, Lineberger Comprehensive Cancer Center, The University of North Carolina Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743426
- Sponsor's protocol ID
- LCCC2247
- Status last verified
- Mar 2026
- First submitted
- 14 Feb 2023
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disease Outcomes and Toxicities in Patients With Gastrointestinal and Sarcomatous Malignancies
- ClinicalTrials.gov ID
- NCT05743426
- Acronym / sponsor ID
- LCCC2247
- Conditions
- Sarcoma, Gastrointestinal Cancer
- Keywords
- toxicity, survey
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 17 Mar 2023 (actual)
- Primary completion
- 1 Jan 2036 (estimated)
- Study completion
- 1 Jan 2036 (estimated)
- First posted
- 24 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | – | Other: Survey, Other: Toxicity AssessmentsSubjects who are with gastrointestinal malignancies or sarcoma receive radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with gastrointestinal malignancy or sarcoma receiving treatment at study center.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyPatient Reported Outcome (PRO) questionnaire | Other | Single Arm |
| Toxicity AssessmentsToxicity Assessments will be performed using the National Cancer Institute Common Terminology Criteria (NCI-CTCAE). | Other | Single Arm |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olivia Roberts contact
Theodore K Yanagihara principal investigator
Lineberger Comprehensive Cancer Center, The University of North Carolina Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoma and Gastrointestinal Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victoria Xu, MD, PhD (+1 984-974-8744, victoria_xu@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: Up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.