Trial Outcomes & Findings for Hypofractionated Radiotherapy for Soft Tissue Sarcomas (NCT NCT03972930)

Last Updated: 2026-05-12

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

48 participants

Primary outcome timeframe

up to 2 years

Results posted on

2026-05-12

Participant Flow

Participants were enrolled at UW Health Hospital from June 2019 to November 2022.

Participant milestones

Participant milestones
Measure	Hypofractionated Radiotherapy for Soft Tissue Sarcoma Participants will be treated with 3-8 fractions, with the maximum prescribed dose to the Planning Tumor Volume (PTV) volume being 60 Gy delivered over a period of at most 8 weeks. Hypofractionated Radiotherapy: Hypofractionated radiation is delivered using highly conformal technique, allowing for a high dose of radiation to be delivered precisely.
Overall Study STARTED	48
Overall Study Participants With 3-month Imaging	42
Overall Study Participants That Did Not Experience Local Failure (Tumor Did Not Return)	37
Overall Study Participants Alive at 2 Years Post Treatment	19
Overall Study Participants With Local Control at 2-years	17
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hypofractionated Radiotherapy for Soft Tissue Sarcomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hypofractionated Radiotherapy for Soft Tissue Sarcoma n=48 Participants Participants will be treated with 3-8 fractions, with the maximum prescribed dose to the Planning Tumor Volume (PTV) volume being 60 Gy delivered over a period of at most 8 weeks. Hypofractionated Radiotherapy: Hypofractionated radiation is delivered using highly conformal technique, allowing for a high dose of radiation to be delivered precisely.
Age, Customized 30-39 years	5 Participants n=1512 Participants
Age, Customized 40-49 years	9 Participants n=1512 Participants
Age, Customized 50-59 years	6 Participants n=1512 Participants
Age, Customized 60-69 years	11 Participants n=1512 Participants
Age, Customized 70-79 years	10 Participants n=1512 Participants
Age, Customized 80-89 years	6 Participants n=1512 Participants
Age, Customized 90-99 years	1 Participants n=1512 Participants
Sex: Female, Male Female	22 Participants n=1512 Participants
Sex: Female, Male Male	26 Participants n=1512 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=1512 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=1512 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=1512 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=1512 Participants
Race (NIH/OMB) Asian	0 Participants n=1512 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=1512 Participants
Race (NIH/OMB) Black or African American	0 Participants n=1512 Participants
Race (NIH/OMB) White	47 Participants n=1512 Participants
Race (NIH/OMB) More than one race	0 Participants n=1512 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=1512 Participants
Region of Enrollment United States	48 participants n=1512 Participants

PRIMARY outcome

Timeframe: up to 2 years

Outcome measures

Outcome measures
Measure	Hypofractionated Radiotherapy for Soft Tissue Sarcoma n=48 Participants Participants will be treated with 3-8 fractions, with the maximum prescribed dose to the Planning Tumor Volume (PTV) volume being 60 Gy delivered over a period of at most 8 weeks. Hypofractionated Radiotherapy: Hypofractionated radiation is delivered using highly conformal technique, allowing for a high dose of radiation to be delivered precisely.	Grade 2 CTCAE Grade 2 are Moderate adverse events.	Grade 3 CTCAE Grade 3 are Severe adverse events.	Grade 4 CTCAE Grade 4 are life threatening adverse events.	Grade 5 CTCAE Grade 5 is death related to an adverse event.
Proportion of Participants With 2-year Local Control	0.352 proportion of participants	—	—	—	—

SECONDARY outcome

Timeframe: up to 2 years

Population: Only 22 patients were alive at 2 years to be evaluated for this measure OR had already experienced local failure and ALSO were evaluated with imaging

2-year local control rates will be reported separately for primary sites vs. metastatic sites.

Outcome measures

Outcome measures
Measure	Hypofractionated Radiotherapy for Soft Tissue Sarcoma n=22 Participants Participants will be treated with 3-8 fractions, with the maximum prescribed dose to the Planning Tumor Volume (PTV) volume being 60 Gy delivered over a period of at most 8 weeks. Hypofractionated Radiotherapy: Hypofractionated radiation is delivered using highly conformal technique, allowing for a high dose of radiation to be delivered precisely.	Grade 2 CTCAE Grade 2 are Moderate adverse events.	Grade 3 CTCAE Grade 3 are Severe adverse events.	Grade 4 CTCAE Grade 4 are life threatening adverse events.	Grade 5 CTCAE Grade 5 is death related to an adverse event.
Proportion of Participants With 2-year Local Control: Primary Site vs Metastatic Site Primary Site	0.888 proportion of participants	—	—	—	—
Proportion of Participants With 2-year Local Control: Primary Site vs Metastatic Site Metastatic Site	0.714 proportion of participants	—	—	—	—

SECONDARY outcome

Timeframe: up to 5 years

5-year local control rates will be reported separately for primary sites vs. metastatic sites with exact 95% CI.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 5 years

The complete response (CR) rate will be reported with an exact 95% CI.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 8 weeks

Unique toxicities tabulated by type and grade.

Outcome measures

Outcome measures
Measure	Hypofractionated Radiotherapy for Soft Tissue Sarcoma n=48 Participants Participants will be treated with 3-8 fractions, with the maximum prescribed dose to the Planning Tumor Volume (PTV) volume being 60 Gy delivered over a period of at most 8 weeks. Hypofractionated Radiotherapy: Hypofractionated radiation is delivered using highly conformal technique, allowing for a high dose of radiation to be delivered precisely.	Grade 2 n=48 Participants CTCAE Grade 2 are Moderate adverse events.	Grade 3 n=48 Participants CTCAE Grade 3 are Severe adverse events.	Grade 4 n=48 Participants CTCAE Grade 4 are life threatening adverse events.	Grade 5 n=48 Participants CTCAE Grade 5 is death related to an adverse event.
Acute Toxicity Tabulated as the Number of Participants Who Experienced Each Adverse Event by Grade Fatigue	7 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Acute Toxicity Tabulated as the Number of Participants Who Experienced Each Adverse Event by Grade Fibrosis	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Acute Toxicity Tabulated as the Number of Participants Who Experienced Each Adverse Event by Grade Insomnia	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Acute Toxicity Tabulated as the Number of Participants Who Experienced Each Adverse Event by Grade Lymphedema	4 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Acute Toxicity Tabulated as the Number of Participants Who Experienced Each Adverse Event by Grade Muscle Weakness	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Acute Toxicity Tabulated as the Number of Participants Who Experienced Each Adverse Event by Grade Myositis	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Acute Toxicity Tabulated as the Number of Participants Who Experienced Each Adverse Event by Grade Nausea	1 Participants	3 Participants	0 Participants	0 Participants	0 Participants
Acute Toxicity Tabulated as the Number of Participants Who Experienced Each Adverse Event by Grade Pain	2 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Acute Toxicity Tabulated as the Number of Participants Who Experienced Each Adverse Event by Grade Radiation Dermatitis	4 Participants	2 Participants	1 Participants	0 Participants	0 Participants
Acute Toxicity Tabulated as the Number of Participants Who Experienced Each Adverse Event by Grade Vomiting	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Acute Toxicity Tabulated as the Number of Participants Who Experienced Each Adverse Event by Grade Erthema multiforme	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Acute Toxicity Tabulated as the Number of Participants Who Experienced Each Adverse Event by Grade Esophagitis	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Acute Toxicity Tabulated as the Number of Participants Who Experienced Each Adverse Event by Grade Anxiety	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Acute Toxicity Tabulated as the Number of Participants Who Experienced Each Adverse Event by Grade Arthralgia	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Acute Toxicity Tabulated as the Number of Participants Who Experienced Each Adverse Event by Grade Decreased Range of Motion	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Acute Toxicity Tabulated as the Number of Participants Who Experienced Each Adverse Event by Grade Diarrhea	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Acute Toxicity Tabulated as the Number of Participants Who Experienced Each Adverse Event by Grade Anorexia	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: up to 5 years

Tabulated by type and grade.

Outcome measures

Outcome data not reported

Adverse Events

Hypofractionated Radiotherapy for Soft Tissue Sarcoma

Serious events: 1 serious events

Other events: 23 other events

Deaths: 27 deaths

Serious adverse events

Serious adverse events
Measure	Hypofractionated Radiotherapy for Soft Tissue Sarcoma n=48 participants at risk Participants will be treated with 3-8 fractions, with the maximum prescribed dose to the Planning Tumor Volume (PTV) volume being 60 Gy delivered over a period of at most 8 weeks. Hypofractionated Radiotherapy: Hypofractionated radiation is delivered using highly conformal technique, allowing for a high dose of radiation to be delivered precisely.
Gastrointestinal disorders Jejunal perforation	2.1% 1/48 • Number of events 1 • Acute toxicities were collected up to 8 weeks and are reported here with Primary Results. All-cause mortality and serious adverse event (SAE) data were collected up to 2 years. Data collection for late toxicities will be collected for up to 5 years. Adverse Events will be amended with late toxicity data when data collection is complete.

Other adverse events

Other adverse events
Measure	Hypofractionated Radiotherapy for Soft Tissue Sarcoma n=48 participants at risk Participants will be treated with 3-8 fractions, with the maximum prescribed dose to the Planning Tumor Volume (PTV) volume being 60 Gy delivered over a period of at most 8 weeks. Hypofractionated Radiotherapy: Hypofractionated radiation is delivered using highly conformal technique, allowing for a high dose of radiation to be delivered precisely.
Metabolism and nutrition disorders Anorexia	4.2% 2/48 • Acute toxicities were collected up to 8 weeks and are reported here with Primary Results. All-cause mortality and serious adverse event (SAE) data were collected up to 2 years. Data collection for late toxicities will be collected for up to 5 years. Adverse Events will be amended with late toxicity data when data collection is complete.
Nervous system disorders Anxiety	2.1% 1/48 • Acute toxicities were collected up to 8 weeks and are reported here with Primary Results. All-cause mortality and serious adverse event (SAE) data were collected up to 2 years. Data collection for late toxicities will be collected for up to 5 years. Adverse Events will be amended with late toxicity data when data collection is complete.
Musculoskeletal and connective tissue disorders Arthralgia	2.1% 1/48 • Acute toxicities were collected up to 8 weeks and are reported here with Primary Results. All-cause mortality and serious adverse event (SAE) data were collected up to 2 years. Data collection for late toxicities will be collected for up to 5 years. Adverse Events will be amended with late toxicity data when data collection is complete.
Musculoskeletal and connective tissue disorders Decreased Range of Motion	2.1% 1/48 • Acute toxicities were collected up to 8 weeks and are reported here with Primary Results. All-cause mortality and serious adverse event (SAE) data were collected up to 2 years. Data collection for late toxicities will be collected for up to 5 years. Adverse Events will be amended with late toxicity data when data collection is complete.
Gastrointestinal disorders Diarrhea	4.2% 2/48 • Acute toxicities were collected up to 8 weeks and are reported here with Primary Results. All-cause mortality and serious adverse event (SAE) data were collected up to 2 years. Data collection for late toxicities will be collected for up to 5 years. Adverse Events will be amended with late toxicity data when data collection is complete.
Skin and subcutaneous tissue disorders Erythema multiforme	2.1% 1/48 • Acute toxicities were collected up to 8 weeks and are reported here with Primary Results. All-cause mortality and serious adverse event (SAE) data were collected up to 2 years. Data collection for late toxicities will be collected for up to 5 years. Adverse Events will be amended with late toxicity data when data collection is complete.
Gastrointestinal disorders Esophagitis	2.1% 1/48 • Acute toxicities were collected up to 8 weeks and are reported here with Primary Results. All-cause mortality and serious adverse event (SAE) data were collected up to 2 years. Data collection for late toxicities will be collected for up to 5 years. Adverse Events will be amended with late toxicity data when data collection is complete.
General disorders Fatigue	16.7% 8/48 • Acute toxicities were collected up to 8 weeks and are reported here with Primary Results. All-cause mortality and serious adverse event (SAE) data were collected up to 2 years. Data collection for late toxicities will be collected for up to 5 years. Adverse Events will be amended with late toxicity data when data collection is complete.
Skin and subcutaneous tissue disorders Fibrosis	2.1% 1/48 • Acute toxicities were collected up to 8 weeks and are reported here with Primary Results. All-cause mortality and serious adverse event (SAE) data were collected up to 2 years. Data collection for late toxicities will be collected for up to 5 years. Adverse Events will be amended with late toxicity data when data collection is complete.
Nervous system disorders Insomnia	2.1% 1/48 • Acute toxicities were collected up to 8 weeks and are reported here with Primary Results. All-cause mortality and serious adverse event (SAE) data were collected up to 2 years. Data collection for late toxicities will be collected for up to 5 years. Adverse Events will be amended with late toxicity data when data collection is complete.
Immune system disorders Lymphedema	10.4% 5/48 • Acute toxicities were collected up to 8 weeks and are reported here with Primary Results. All-cause mortality and serious adverse event (SAE) data were collected up to 2 years. Data collection for late toxicities will be collected for up to 5 years. Adverse Events will be amended with late toxicity data when data collection is complete.
Musculoskeletal and connective tissue disorders Muscle Weakness	2.1% 1/48 • Acute toxicities were collected up to 8 weeks and are reported here with Primary Results. All-cause mortality and serious adverse event (SAE) data were collected up to 2 years. Data collection for late toxicities will be collected for up to 5 years. Adverse Events will be amended with late toxicity data when data collection is complete.
Musculoskeletal and connective tissue disorders Myositis	4.2% 2/48 • Acute toxicities were collected up to 8 weeks and are reported here with Primary Results. All-cause mortality and serious adverse event (SAE) data were collected up to 2 years. Data collection for late toxicities will be collected for up to 5 years. Adverse Events will be amended with late toxicity data when data collection is complete.
Gastrointestinal disorders Nausea	8.3% 4/48 • Acute toxicities were collected up to 8 weeks and are reported here with Primary Results. All-cause mortality and serious adverse event (SAE) data were collected up to 2 years. Data collection for late toxicities will be collected for up to 5 years. Adverse Events will be amended with late toxicity data when data collection is complete.
General disorders Pain	8.3% 4/48 • Acute toxicities were collected up to 8 weeks and are reported here with Primary Results. All-cause mortality and serious adverse event (SAE) data were collected up to 2 years. Data collection for late toxicities will be collected for up to 5 years. Adverse Events will be amended with late toxicity data when data collection is complete.
Skin and subcutaneous tissue disorders Radiation dermatitis	14.6% 7/48 • Acute toxicities were collected up to 8 weeks and are reported here with Primary Results. All-cause mortality and serious adverse event (SAE) data were collected up to 2 years. Data collection for late toxicities will be collected for up to 5 years. Adverse Events will be amended with late toxicity data when data collection is complete.
Gastrointestinal disorders Vomiting	2.1% 1/48 • Acute toxicities were collected up to 8 weeks and are reported here with Primary Results. All-cause mortality and serious adverse event (SAE) data were collected up to 2 years. Data collection for late toxicities will be collected for up to 5 years. Adverse Events will be amended with late toxicity data when data collection is complete.

Additional Information

Zachary Morris, MD, PhD

UW School of Medicine and Public Health

Phone: (608) 263-2603

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place