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NCT04562480 · ClinicalTrials.gov registry record · Phase 2
Radiation Therapy Before Surgery for Localized, Resectable Soft Tissue Sarcoma of the Extremity and Superficial Trunk
A Phase 2 study of Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 and Resectable Soft Tissue Sarcoma, sponsored by Mayo Clinic.
- Active
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 3
- Study locations
NCT04562480: Active Phase 2 study of Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 and Resectable Soft Tissue Sarcoma, sponsored by Mayo Clinic.
NCT04562480 is a Phase 2 study of Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 and Resectable Soft Tissue Sarcoma that is active but no longer recruiting, run by Mayo Clinic. The registered enrollment target is 120 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04562480, a Phase 2 study of Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 and Resectable Soft Tissue Sarcoma, is active but no longer recruiting, sponsored by Mayo Clinic.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase II trial investigates the effects of hypofractionated radiation therapy before surgery on wound complications associated with surgery in treating patients with soft tissue sarcoma of the extremity (arms, hands, legs or feet) and superficial trunk that has not spread to other parts of the body (localized) and can be removed by surgery (resectable). Hypofractionated is a shorter radiation therapy treatment length (fewer radiation treatment days) and administers the total radiation dose as larger daily doses, compared to conventionally fractionated therapy.
Primary Outcome
Will be assessed by the number of patients who experience major wound complications within 120 days following surgery. Major wound complication is defined as secondary unplanned operation under general or regional anesthesia for wound repair (e.g., debridement, operative drainage, or secondary wound closure including rotationplasty, free flaps or skin grafts); or wound management without secondary operation including invasive procedures (e.g., aspiration of seroma or readmission for wound care s
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- RADIATION Hypofractionated Radiation Therapy
- PROCEDURE Resection
Study Locations (3)
Arizona
- Mayo Clinic in Arizona - Scottsdale
Florida
- Mayo Clinic in Florida - Jacksonville
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2020-11-30 |
| Est. Completion | 2029-10-31 |
| Phase | Phase 2 |
What the registry record for NCT04562480 still lists
NCT04562480 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower).
The record links to 5 conditions, with Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 appearing as the primary indexed condition, and to 4 interventions - of which Quality-of-Life Assessment is the first listed.
NCT04562480 reports a single indexed study location in Arizona, Florida, Minnesota.
Frequently Asked Questions
What is clinical trial NCT04562480 about?
NCT04562480 is a clinical study titled "Radiation Therapy Before Surgery for Localized, Resectable Soft Tissue Sarcoma of the Extremity and Superficial Trunk". This phase II trial investigates the effects of hypofractionated radiation therapy before surgery on wound complications associated with surgery in treating patients with soft tissue sarcoma of the extremity (arms, hands, legs or feet) and superficial trunk that has not spread to other parts of the ...
What is the current status of trial NCT04562480?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2020-11-30. Estimated completion is 2029-10-31.
What conditions does trial NCT04562480 study?
This clinical trial studies the following conditions: Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, Resectable Soft Tissue Sarcoma, Stage I Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, Stage IA Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, Stage IB Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8.
What interventions are being tested in trial NCT04562480?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Hypofractionated Radiation Therapy (RADIATION), Resection (PROCEDURE).
Who is sponsoring clinical trial NCT04562480?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04562480 being conducted?
This trial has 3 study locations across Arizona, Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04562480's enrollment target sits among peer trials
120 569th of 2000 higher than 1,383 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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