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NCT05776667 · ClinicalTrials.gov registry record · NA
Feasibility Trial of Preoperative 5-Day Hypofractionated Radiotherapy for Primary Soft Tissue Sarcoma
A NA study of Soft Tissue Sarcoma, sponsored by Medical University of South Carolina.
- Active
- Registry status
- NA
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT05776667 is a NA study of Soft Tissue Sarcoma that is active but no longer recruiting, run by Medical University of South Carolina. The registered enrollment target is 16 participants, below the 79-participant average among 55 other Soft Tissue Sarcoma trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05776667, a NA study of Soft Tissue Sarcoma, is active but no longer recruiting, sponsored by Medical University of South Carolina.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is investigating the feasibility of preoperative 5-day hypofractionated radiotherapy (HFRT) for extremity soft tissue sarcoma (STS). The primary objective is to assess the uptake of 5-day HFRT in patients with STS who are candidates for preoperative radiotherapy and limb preserving surgery. Secondary objectives include evaluation of the rates of favorable pathologic response, major wound complications, local control, acute toxicity, and 1-year late toxicity will be assessed. Exploratory objectives include evaluation of the impact of preoperative 5-day HFRT on access to care, the socio-demographic profile of the trial participants will be compared to that of extremity STS patients seen within Hollings Cancer Center (HCC) and recommended preoperative conventional fractionation radiotherapy (CFRT) in the 3 years prior to the study opening. The retention rate for radiotherapy at HCC in patients meeting trial criteria during the prior 3 years will be compared with the retention rate for radiotherapy during the study period. An exploratory analysis will measure serum SFRP2 pre- and post- radiotherapy to assess changes in response to preoperative 5-day HFRT. Changes in serum SFRP2 will be evaluated for association with a favorable pathologic response to determine the potential of serum SFRP2 as a predictive biomarker. Patient satisfaction with the decision to participate in a trial of preoperative 5-day HFRT will be assessed.
Conditions Studied
Interventions
- RADIATION Hypofractionated Radiation Therapy
Study Locations (1)
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2023-08-15 |
| Est. Completion | 2026-11-18 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05776667
The ClinicalTrials.gov registry entry for NCT05776667 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 79-participant average among 55 other Soft Tissue Sarcoma trials with a reported enrollment target (80% lower). The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Soft Tissue Sarcoma appearing as the primary indexed condition, and to 1 intervention - of which Hypofractionated Radiation Therapy is the first listed.
NCT05776667 reports 1 study location spanning 1 distinct geographic area - top geographies include South Carolina.
Frequently Asked Questions
What is clinical trial NCT05776667 about?
NCT05776667 is a clinical study titled "Feasibility Trial of Preoperative 5-Day Hypofractionated Radiotherapy for Primary Soft Tissue Sarcoma". This study is investigating the feasibility of preoperative 5-day hypofractionated radiotherapy (HFRT) for extremity soft tissue sarcoma (STS). The primary objective is to assess the uptake of 5-day HFRT in patients with STS who are candidates for preoperative radiotherapy and limb preserving surger...
What is the current status of trial NCT05776667?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 16 participants. The study started on 2023-08-15. Estimated completion is 2026-11-18.
What conditions does trial NCT05776667 study?
This clinical trial studies the following conditions: Soft Tissue Sarcoma.
What interventions are being tested in trial NCT05776667?
The interventions under investigation include: Hypofractionated Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT05776667?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05776667 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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