Disease Outcomes and Toxicities in Patients With Gastrointestinal and Sarcomatous Malignancies

NCT ID: NCT05743426

Last Updated: 2025-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-17

Study Completion Date

2036-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Sarcoma Gastrointestinal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Single Arm

Subjects who are with gastrointestinal malignancies or sarcoma receive radiotherapy.

Survey

Intervention Type OTHER

Patient Reported Outcome (PRO) questionnaire

Toxicity Assessments

Intervention Type OTHER

Toxicity Assessments will be performed using the National Cancer Institute Common Terminology Criteria (NCI-CTCAE).

Interventions

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Survey

Patient Reported Outcome (PRO) questionnaire

Intervention Type OTHER

Toxicity Assessments

Toxicity Assessments will be performed using the National Cancer Institute Common Terminology Criteria (NCI-CTCAE).

Intervention Type OTHER

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Theodore K Yanagihara

Role: PRINCIPAL_INVESTIGATOR

Lineberger Comprehensive Cancer Center, The University of North Carolina Chapel Hill

Locations

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University of North Carolina at Chapel Hill, Department of Radiation Oncology

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Victoria Xu, MD, PhD

Role: CONTACT

+1 984-974-8744

Olivia Roberts

Role: CONTACT

Facility Contacts

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Victoria Xu

Role: primary

984-974-8744

Related Links

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http://unclineberger.org/patientcare/clinical-trials/clinical-trials

University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Other Identifiers

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LCCC2247

Identifier Type: -

Identifier Source: org_study_id

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