NCT05109494 Hypofractionated vs Conventional Fractionated RT in Soft Tissue Sarcomas
| NCT ID | NCT05109494 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Wisconsin, Madison |
| Condition | Soft Tissue Sarcoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2022-04-06 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2022-04-06 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This research study is designed to find out if radiation therapy treatment prior to surgery is safe and effective to treat soft tissue sarcomas. 30 participants with soft tissue sarcoma will be enrolled and can expect to be on study for up to 5 years.
Eligibility Criteria
Inclusion Criteria: * Biopsy proven soft tissue sarcoma of the extremity, trunk, or head and neck * No prior sarcoma-directed chemotherapy or radiotherapy * Age ≥ 18 years * Karnofsky performance status ≥ 60 * Able to understand and sign an informed consent * Life expectancy of greater than 12 weeks * Hypofractionated or conventionally fractionated radiotherapy using Intensity Modulated Radiation Therapy (IMRT) are both deemed feasible and safe neoadjuvant treatments, at the treating physician's discretion * Operable disease and medically fit for surgery, based on the opinion of the consulting surgeon; surgery within 5-14 days of completion of radiation therapy (RT) * Adequate bone marrow function as defined by absolute neutrophil count \> 500/mcL, hemoglobin \> 8 g/dL, platelets \> 50,000/mcL; adequate renal function as defined by creatinine clearance \> 30 mL/min Exclusion Criteria: * Pregnant * Unable to undergo imaging or positioning necessary for radiotherapy planning
Contact & Investigator
Zachary Morris, MD, PhD
PRINCIPAL INVESTIGATOR
UW School of Medicine and Public Health
Frequently Asked Questions
Who can join the NCT05109494 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Soft Tissue Sarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05109494 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05109494 currently recruiting?
Yes, NCT05109494 is actively recruiting participants. Contact the research team at clinicaltrials@cancer.wisc.edu for enrollment information.
Where is the NCT05109494 trial being conducted?
This trial is being conducted at Madison, United States.
Who is sponsoring the NCT05109494 clinical trial?
NCT05109494 is sponsored by University of Wisconsin, Madison. The principal investigator is Zachary Morris, MD, PhD at UW School of Medicine and Public Health. The trial plans to enroll 30 participants.