An interventional study of Hypofractionated Radiation Therapy in Soft Tissue Sarcoma, sponsored by Medical College of Wisconsin. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Medical College of Wisconsin · Not applicable, Interventional, and Treatment
This is a nonrandomized Phase II pilot protocol to determine the feasibility, toxicity and disease control (local control, overall and progression-free survival) using hypofractionated preoperative radiation therapy in patients with primary localized soft tissue sarcomas (STS).
BACKGROUND OVERVIEW: Hypofractionation has several potential advantages over conventional radiation. First, the biological equivalent dose to the tumor is higher with hypofractionation than it is with conventional radiation. In between radiation treatments there is repair of the radiation damaged cancer cells (on a cell survival curve this region of repair is referred to as the "shoulder" of the curve). Some cell lines are better at repair than others. Sarcoma is often referred to as a "radioresistant" tumor, which means that sarcoma cell lines have a larger capacity for radiation repair than do other cell lines. A treatment that can deliver a high dose in fewer fractions can potentially overcome some of this repair. There is a concept in radiation known as "biologically equivalent dose" (BED) which states that a higher dose per fraction results in more tumor kill than a lower dose per fraction. For example, radiation delivered to a total of 60 Gy in three 20 Gy fractions is the equivalent of 150 Gy in 2 Gy fractions.
BACKGROUND RATIONALE: It is important to conduct this study because hypofractionation not only decreases treatment package time and cost of care, but it also potentially improves patient convenience and quality of life and could impact radiologic and pathologic variables in a positive way by leading to more tumor cell kill. This could potentially change the paradigm of the current management of STS of the extremity and chest-wall.
HYPOTHESIS: Preoperative hypofractionated radiation therapy for localized soft tissue sarcomas (STS) will result in local control and toxicity similar to conventional fractionation with less cost, more patient convenience and decreased overall treatment time.
TREATMENT: Image-guided radiation therapy is mandatory. PREOPERATIVE: (1) Either 3D conformal radiotherapy or intensity modulated radiation therapy (IMRT). (2) A prescription dose of 35 Gy in 5 fractions given every other day with at least 48 hours in between each fraction will be prescribed to cover 95% of the planning target volume. TREATMENT SCHEDULE: Treatments will have a minimum of a 48-hour interfraction interval. Treatments will be completed over 20 days maximum.
1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
This study's enrollment of 35 is below the median of 40 across 1,283 interventional studies indexed under Sarcoma.
Browse Sarcoma studies →Medical College of Wisconsin is the lead sponsor of 540 studies on the registry; 120 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 56 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Radiation treatment in which the total dose of radiation is divided into large doses and treatments are given every other day. Hypofractionated radiation therapy is given over a shorter period of time (fewer days or weeks) than standard radiation therapy.
Radiation: Hypofractionated Radiation Therapy
Treatments will have a minimum of a 48-hour interfraction interval. Treatments will be completed over 20 days maximum.
Local Disease Control Assessed by Physical Examination
This measure will capture the number of subjects experiencing a recurrence of the primary lesion assessed by physical examination.
Time frame: 2 Years
Local Disease Control Assessed by Magnetic Resonance Imaging (MRI)
This measure is the number of subjects experiencing a recurrence of the primary lesion as assessed by MRI.
Time frame: 2 years
Musculoskeletal Tumor Rating Scale (MSTS) Score
Toxicity will be assessed at specific times the Musculoskeletal Tumor Rating Scale. The MSTS evaluates: pain, function, emotional acceptance, hand positioning, dexterity and lifting ability, using a six-item Likert scale ranging from 0 (worst condition) to 5 (best condition). The individual scores are added for the MSTS Score, range 0 to 30. A higher score indicates better function.
Time frame: Baseline, prior to surgery and 24 months after surgery
Disease-free Survival
Disease-free survival will measure the time in months from initiation of radiation therapy until documented recurrence of disease. Patients who are disease-free and alive at the time of analysis will be censored at the time of their last follow-up. Patients will be assessed for disease-free survival at 2 years.
Time frame: 2 Years
Overall Survival
Overall survival will measure the time from initiation of radiation therapy until documented death from any cause. Patients who are alive at the time of analysis will be censored at the time of their last follow-up. Patients will be assessed for overall survival at 2 years.
Time frame: 2 Years
Radiologic Changes Due to Hypofractionated Radiation.
This measure will assess the size of enhancement due to hypofractionated radiation.
Time frame: 4 weeks after radiation therapy
Pathologic Changes Due to Hypofractionated Radiation.
This measure will capture the fibrosis present in tissue specimens as a percent.
Time frame: 2 weeks after surgery
Treatment-related Necrosis and Fibrosis
Number of participants who experienced treatment-related necrosis and fibrosis ≥90%.
Time frame: 2 years
| Milestone | Hypofractionated Radiation Therapy |
|---|---|
| Started | 35 |
| Completed | 31 |
| Not completed | 4 |
| Withdrew: Death | 4 |
This measure will capture the number of subjects experiencing a recurrence of the primary lesion assessed by physical examination.
| Participants | Hypofractionated Radiation Therapy |
|---|---|
| Local Disease Control Assessed by Physical Examination | 0 |
This measure is the number of subjects experiencing a recurrence of the primary lesion as assessed by MRI.
| Participants | Hypofractionated Radiation Therapy |
|---|---|
| Local Disease Control Assessed by Magnetic Resonance Imaging (MRI) | 0 |
Toxicity will be assessed at specific times the Musculoskeletal Tumor Rating Scale. The MSTS evaluates: pain, function, emotional acceptance, hand positioning, dexterity and lifting ability, using a six-item Likert scale ranging from 0 (worst condition) to 5 (best condition). The individual scores are added for the MSTS Score, range 0 to 30. A higher score indicates better function.
| units on a scale | Hypofractionated Radiation Therapy |
|---|---|
| Baseline | 29 ± 1.05 |
| Prior to Surgery | 28.3 ± 2.06 |
| 2 years | 27.3 ± 2.47 |
Disease-free survival will measure the time in months from initiation of radiation therapy until documented recurrence of disease. Patients who are disease-free and alive at the time of analysis will be censored at the time of their last follow-up. Patients will be assessed for disease-free survival at 2 years.
| Participants | Hypofractionated Radiation Therapy |
|---|---|
| Disease-free Survival | 32 |
Overall survival will measure the time from initiation of radiation therapy until documented death from any cause. Patients who are alive at the time of analysis will be censored at the time of their last follow-up. Patients will be assessed for overall survival at 2 years.
| Participants | Hypofractionated Radiation Therapy |
|---|---|
| Overall Survival | 32 |
This measure will assess the size of enhancement due to hypofractionated radiation.
| cubic centimeters | Hypofractionated Radiation Therapy |
|---|---|
| Radiologic Changes Due to Hypofractionated Radiation. | -16.2 ± 25 |
This measure will capture the fibrosis present in tissue specimens as a percent.
| percentage of tumor specimen | Hypofractionated Radiation Therapy |
|---|---|
| Necrosis | 17.5 ± 26.4429 |
| Fibrosis | 20 ± 32.5364 |
| Viable Cells | 50 ± 31.9287 |
Number of participants who experienced treatment-related necrosis and fibrosis ≥90%.
| Participants | Hypofractionated Radiation Therapy |
|---|---|
| Treatment-related necrosis | 4 |
| Treatment-related fibrosis | 4 |
Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hypofractionated Radiation Therapy | 4/35 (11.4%) | 19/35 (54.3%) | 20/35 (57.1%) |
| Event | Hypofractionated Radiation Therapy |
|---|---|
| Wound infectionInfections and infestations | 4/35 |
| Wound infectionInfections and infestations | 3/35 |
| Wound complicationInjury, poisoning and procedural complications | 3/35 |
| Wound dehiscenceInjury, poisoning and procedural complications | 2/35 |
| Cardiac arrestCardiac disorders | 1/35 |
| Hyper parathyroidismEndocrine disorders | 1/35 |
| PainGeneral disorders | 1/35 |
| SeromaInjury, poisoning and procedural complications | 1/35 |
| Ejection fraction decreasedInvestigations | 1/35 |
| HypercalcemiaMetabolism and nutrition disorders | 1/35 |
| Event | Hypofractionated Radiation Therapy |
|---|---|
| Edema limbsGeneral disorders | 3/35 |
| Localized edemaGeneral disorders | 3/35 |
| Radiation dermatitisInjury, poisoning and procedural complications | 3/35 |
| SeromaInjury, poisoning and procedural complications | 2/35 |
| FallInjury, poisoning and procedural complications | 1/35 |
| Postoperative hemorrhageInjury, poisoning and procedural complications | 1/35 |
| Superficial soft tissue fibrosisMusculoskeletal and connective tissue disorders | 1/35 |
| Myelodysplastic syndromeNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/35 |
| SyncopeNervous system disorders | 1/35 |
| Dry skinSkin and subcutaneous tissue disorders | 1/35 |
| Age, Categorical(Participants) | Hypofractionated Radiation Therapy |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 17 |
| >=65 years | 18 |
| Age, Continuous(years) | Hypofractionated Radiation Therapy |
|---|---|
| Mean | 63.2 ± 15.4 |
| Sex: Female, Male(Participants) | Hypofractionated Radiation Therapy |
|---|---|
| Female | 16 |
| Male | 19 |
| Ethnicity (NIH/OMB)(Participants) | Hypofractionated Radiation Therapy |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 33 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Hypofractionated Radiation Therapy |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 33 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Hypofractionated Radiation Therapy |
|---|---|
| United States | 35 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Medical College of Wisconsin