Soft Tissue Sarcoma
Conditions
Keywords
Hypofractionated Radiotherapy
Brief summary
One of the main challenges in treating sarcomas with radiation is the toxicity to normal structures around the sarcoma. Early reports suggest Hypofractionated Radiotherapy will be safe and effective for treatment of soft tissue sarcomas. However, given the rarity of this disease, the diversity of histological sub-types, and the variety of locations where these can occur (anywhere in the body), more data is needed to provide understanding of the safety and efficacy of hypofractionated radiotherapy for treatment of this disease. The hypothesis is that by using hypofractionated radiotherapy, highly conformal high dose radiation can be delivered to soft tissue sarcomas, while respecting established normal tissue constraints and that local control rates will be greater than historical rates reported with conventional fractionation. Eligible participants with biopsy proven soft tissue sarcoma will be on study for up to 60 months.
Interventions
RADIATIONHypofractionated Radiotherapy
Hypofractionated radiation is delivered using highly conformal technique, allowing for a high dose of radiation to be delivered precisely.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Biopsy proven soft tissue sarcoma, either localized and inoperable/unresectable or metastatic, that is deemed by the treating physician to be targetable with hypofractionated radiotherapy. * Participant refuses surgery or is aware that surgery is not recommended for them * Karnofsky performance status \> 60 * Able to understand and sign an informed consent form
Exclusion criteria
* Pregnant * Chemotherapy or systemic anti-cancer treatment within the preceding two weeks * Unable to undergo imaging or positioning necessary for radiotherapy planning * Prior radiation therapy in the field that, at the discretion of the treating physician, prevents safe delivery of hypofractionated radiotherapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With 2-year Local Control | up to 2 years | The primary endpoint is 2-year local control, defined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions, Progressive Disease (PD), at least a 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient change for PR, PD, or CR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With 2-year Local Control: Primary Site vs Metastatic Site | up to 2 years | 2-year local control rates will be reported separately for primary sites vs. metastatic sites. |
| Proportion of Participants With 5-year Local Control: Primary Site vs Metastatic Site | up to 5 years | 5-year local control rates will be reported separately for primary sites vs. metastatic sites with exact 95% CI. |
| Complete Response Rate | up to 5 years | The complete response (CR) rate will be reported with an exact 95% CI. |
| Progression Free Survival | up to 5 years | Progression free survival (PFS) defined with follow-up radiological assessment with PFS calculated from the point of start of hypofractionated radiotherapy to the point of recurrence or death. Participants without documented progression who are alive at last follow-up will be censored at the date of the last radiologic assessment. PFS will be estimated using the Kaplan-Meier method. |
| Overall Survival | up to 5 years | Overall survival (OS) defined from the point of start of hypofractionated radiotherapy to the time of death or last follow-up if alive. Participants who are alive at last follow-up will be censored. OS will be estimated using the Kaplan-Meier method. |
| Acute Toxicity Tabulated as the Number of Participants Who Experienced Each Adverse Event by Grade | up to 8 weeks | Unique toxicities tabulated by type and grade. |
| Incidence of Long Term Toxicity | up to 5 years | Tabulated by type and grade. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORZachary Morris, MD, PhD
University of Wisconsin, Madison
Participant flow
Recruitment details
Participants were enrolled at UW Health Hospital from June 2019 to November 2022.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized 30-39 years | 5 Participants |
| Age, Customized 40-49 years | 9 Participants |
| Age, Customized 50-59 years | 6 Participants |
| Age, Customized 60-69 years | 11 Participants |
| Age, Customized 70-79 years | 10 Participants |
| Age, Customized 80-89 years | 6 Participants |
| Age, Customized 90-99 years | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 47 Participants |
| Region of Enrollment United States | 48 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 27 / 48 |
| other Total, other adverse events | 23 / 48 |
| serious Total, serious adverse events | 1 / 48 |
Outcome results
None listed