Clinical trial NCT03972930: Hypofractionated Radiotherapy for Soft Tissue Sarcomas
Official title: Phase 2 Trial of Hypofractionated Radiotherapy for Soft Tissue Sarcomas
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Soft Tissue Sarcoma
Keywords: Hypofractionated Radiotherapy
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of Participants with 2-year Local Control
timeFrame: up to 2 years
Secondary outcomes:
measure: Proportion of Participants with 2-year Local Control: Primary Site vs Metastatic Site
timeFrame: up to 2 years
measure: Proportion of Participants with 5-year Local Control: Primary Site vs Metastatic Site
timeFrame: up to 5 years
measure: Complete Response Rate
timeFrame: up to 5 years
measure: Progression Free Survival
timeFrame: up to 5 years
measure: Overall Survival
timeFrame: up to 5 years
measure: Incidence of Acute Toxicity
timeFrame: up to 8 weeks
measure: Incidence of Long Term Toxicity
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Zachary Morris, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: