Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Version 11/21/2024 | Other Identifier | UW Madison | |
| A533300 | Other Identifier | UW Madison | |
| NCI-2021-11388 | Registry Identifier | NCI CTRP | |
| 2021-0957 | Other Identifier | UW HSIRB |
Not provided
Not provided
Not provided
Administrative
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Standard treatment for soft tissue sarcomas is a combination of radiation therapy and surgery. Radiation therapy is usually done prior to the surgical removal of the tumor. Most commonly, conventionally fractionated radiotherapy is used for soft tissue sarcomas, in which radiation therapy is given over 25 treatments in a time period of approximately 5 weeks.
Conventionally fractionated radiotherapy is radiation treatment that is delivered over the course of several days; typically divided into doses that are delivered each weekday over a set number of weeks. Each radiation treatment is called a "dose fraction", thus the name "fractionated".
Hypofractionated radiotherapy is a technique in which a higher dose of radiation is given over a fewer number of treatments. Early studies have suggested that hypofractionated radiotherapy will be safe and effective for pre-operative treatment of soft tissue sarcomas. However, because this disease is rare, there are different kinds of soft tissue sarcomas, these tumors can occur anywhere in the body, and conventionally fractionated radiotherapy remains standard, more study is needed to find out if hypofractionated radiotherapy is a safe and effective treatment for this disease.
Therefore, the investigators plan to compare patients treated with conventionally fractionated radiotherapy over 25 treatments in a time period of 5 weeks to patients treated with hypofractionated radiotherapy over 5 treatments in a time period of 1-2 weeks.
The investigators hypothesize hypofractionated radiotherapy in the pre-operative treatment of soft tissue sarcomas can effectively treat soft tissue sarcomas while minimizing side effects and minimizing the time between diagnosis and surgical resection.
Patients with liposarcoma (LPS) or undifferentiated pleomorphic sarcoma (UPS) may receive standard of care pembrolizumab concurrently with radiation therapy at the discretion of their treating medical oncologist.
Primary Objective
Secondary Objectives
Exploratory Objectives
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Fractionated | Active Comparator | radiation treatments will be delivered daily, delivered over a maximum of 7 weeks from the first treatment, surgery will be within 5-14 days of completion of RT |
|
| Hypofractionated | Experimental | the maximum frequency of treatment will be every day and the minimum frequency will be every other day, delivered over a maximum of 3 weeks from the first treatment, surgery will be within 5-14 days of completion of RT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional Fractionated | Radiation | 50 Gy in 25 fractions will be prescribed to cover 95% of the planning tumor volume (PTV). More than 99% of the PTV should receive > 97% of the prescribed dose. For dose homogeneity, no more than 20% of the PTV will receive ≥ 110% prescription dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Necrosis Score on Surgical Pathology Report | scores range from 0 to 2, lower scores mean there was less dying tissue present | up to 12 weeks from randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Surgical Margin Status R0, R1, and R2 | Pathology will determine the residual disease status on surgically resected tumor margin and classify it as R0 for no microscopic residual disease; R1 for microscopic residual disease; and R2 for gross residual disease. Incidence of margin status on the Surgical Pathology Report will be reported. | up to 12 weeks from randomization |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zachary Morris, MD, PhD | UW School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53705 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069473 | Radiation Dose Hypofractionation |
| ID | Term |
|---|---|
| D019583 | Dose Fractionation, Radiation |
| D011879 | Radiotherapy Dosage |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
Not provided
Not provided
Participants will be randomized by the University of Wisconsin clinical trials team to conventional versus hypofractionated RT. Randomization will be blocked to maintain balance over time, with blocks randomly assigned to sizes of 4 or 6. The randomization will take into account receipt of immunotherapy, to allow for a balance of patients in both arms.
Not provided
Not provided
Not provided
Not provided
|
| Hypofractionated | Radiation | 27.5 Gy in 5 fractions will be prescribed to cover 95% of the PTV. More than 99% of the PTV should receive > 97% of the prescribed dose |
|
| Incidence of acute wound healing complications up to 120 days after surgery | Requiring one of the following:
| up to 6 months from randomization (up to 120 days after surgery) |
| Incidence of secondary operation for wound repair | Secondary operation defined as occurring under general or regional anesthesia with a purpose of wound repair or wound management after surgical resection | up to 6 months from randomization (up to 120 days after surgery) |
| Incidence of Late Toxicity |
| up to 2 years plus or minus 3 months |
| Progression Free Survival (PFS) | PFS defined from randomization to the point of recurrence or death. Follow-up radiological assessment and biopsy when indicated. | up to 5 years |
| Rate of Local Tumor Recurrence | up to 5 years |