Comparing two types of radiation therapy for soft tissue sarcomas
Phase II Trial of Neoadjuvant Hypofractionated Radiotherapy Versus Conventionally Fractionated Radiotherapy for Soft Tissue Sarcomas
This study is testing if a shorter, more intense radiation treatment can be just as safe and effective as the standard radiation for people with soft tissue sarcomas before surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Drugs / interventions | chemotherapy, Radiation, pembrolizumab |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT05109494 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and effectiveness of hypofractionated radiotherapy compared to conventional fractionated radiotherapy for patients with soft tissue sarcomas prior to surgery. A total of 30 participants will be enrolled, receiving either treatment over different time frames: 25 treatments over 5 weeks for conventional therapy or 5 treatments over 1-2 weeks for hypofractionated therapy. The goal is to determine if the shorter treatment duration with higher doses is a viable alternative to the standard approach. Participants can expect to be involved in the study for up to 5 years.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with biopsy-proven soft tissue sarcoma of the extremity, trunk, or head and neck who are operable and medically fit for surgery.
Not a fit: Patients who are pregnant or unable to undergo necessary imaging or positioning for radiotherapy planning will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more efficient and effective treatment option for patients with soft tissue sarcomas.
How similar studies have performed: Early studies have suggested that hypofractionated radiotherapy may be safe and effective, but further research is needed to confirm these findings in the context of soft tissue sarcomas.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Madison, Wisconsin
- University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Zachary Morris, MD, PhD — UW School of Medicine and Public Health
- Study coordinator: Cancer Connect
- Email: clinicaltrials@cancer.wisc.edu
- Phone: 800-622-8922
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.