Soft Tissue SarcomaNCT02634710
Hypofractionated Pre-operative Radiation Therapy for Soft Tissue Sarcomas of the Extremity and Chest-wall
A study testing Hypofractionated Radiation Therapy in people with Soft Tissue Sarcoma, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- Hypofractionated Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2016to 14 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- Core needle biopsy obtained
- Pathologic confirmation of primary soft tissue sarcoma of the upper or lower extremity or chest-wall.
- Stage I-III Soft Tissue Sarcoma of the extremity without evidence of metastatic disease
- Medically operable
- No prior radiotherapy to primary site or adjacent site that results in overlapping radiation fields.
Show all 10Show fewer
- MRI obtained of the affected extremity or chest-wall
- CT chest acquired to assess distant disease
- Karnofsky Performance Status (KPS) 60 or above
- Informed consent obtained prior to study entry
Who cannot join
- Patients who have metastatic disease
- Pregnant women
- Women of childbearing potential and male participants must practice adequate contraception.
- Disease pathology other than sarcoma subtypes
- Patients with a history of metastatic disease from a primary other than sarcoma
- Patients who cannot undergo MRI as part of pre-treatment or treatment planning process
- STS of non-extremity or chest-wall regions
- Tumor size ≥ 20 cm maximal dimension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study Evaluating Hypofractionated Pre-operative Radiation Therapy for Soft Tissue Sarcomas of the Extremity and Chest-wall
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).
Read the detailed description
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.
- Conditions
- Soft Tissue Sarcoma
- Being tested
- Hypofractionated Radiation Therapy
- Keywords
- soft tissue sarcoma
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated Radiation TherapyRadiation
Treatments will have a minimum of a 48-hour interfraction interval. Treatments will be completed over 20 days maximum.
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated Radiation Therapy | Experimental | 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. Receives: Radiation: Hypofractionated Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 years
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 2 Years
Radiologic Changes Due to Hypofractionated Radiation.
This measure will assess the size of enhancement due to hypofractionated radiation.
Measured: 4 weeks after radiation therapy
Pathologic Changes Due to Hypofractionated Radiation.
This measure will capture the fibrosis present in tissue specimens as a percent.
Measured: 2 weeks after surgery
Treatment-related Necrosis and Fibrosis
Number of participants who experienced treatment-related necrosis and fibrosis ≥90%.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study start23 Feb 2016
- Primary completion18 May 2022
- Study completion14 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ciani M Ellison, MD, Medical College of Wisconsin
- Investigators
- Ciani Ellison, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02634710
- Sponsor's protocol ID
- 25722
- Status last verified
- Nov 2025
- First submitted
- 4 Nov 2015
- Last updated
- 2 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Bedi M, Singh R, Charlson JA, Kelly T, Johnstone C, Wooldridge A, Hackbarth DA, Moore N, Neilson JC, King DM. Is 5 the New 25? Long-Term Oncologic Outcomes From a Phase II, Prospective, 5-Fraction Preoperative Radiation Therapy Trial in Patients With Localized Soft Tissue Sarcoma. Adv Radiat Oncol. 2022 Jan 25;7(3):100850. doi: 10.1016/j.adro.2021.100850. eCollection 2022 May-Jun.
PubMed 35647402
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating Hypofractionated Pre-operative Radiation Therapy for Soft Tissue Sarcomas of the Extremity and Chest-wall
- ClinicalTrials.gov ID
- NCT02634710
- Acronym / sponsor ID
- 25722
- Conditions
- Soft Tissue Sarcoma
- Keywords
- soft tissue sarcoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 23 Feb 2016 (actual)
- Primary completion
- 18 May 2022 (actual)
- Study completion
- 14 Jun 2022 (actual)
- First posted
- 18 Dec 2015 (estimated)
- Results
- Posted 13 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated Radiation Therapy | Experimental | Radiation: Hypofractionated Radiation TherapyRadiation 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ≥ 18 years of age
- Core needle biopsy obtained
- Pathologic confirmation of primary soft tissue sarcoma of the upper or lower extremity or chest-wall.
- Stage I-III Soft Tissue Sarcoma of the extremity without evidence of metastatic disease
- Medically operable
Key exclusion criteria (8 listed)
- Patients who have metastatic disease
- Pregnant women
- Women of childbearing potential and male participants must practice adequate contraception.
- Disease pathology other than sarcoma subtypes
- Patients with a history of metastatic disease from a primary other than sarcoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypofractionated Radiation TherapyTreatments will have a minimum of a 48-hour interfraction interval. Treatments will be completed over 20 days maximum. | Radiation | Hypofractionated Radiation Therapy |
Primary outcome
Local Disease Control Assessed by Physical Examination
Time frame: 2 Years
This measure will capture the number of subjects experiencing a recurrence of the primary lesion assessed by physical examination.
Local Disease Control Assessed by Magnetic Resonance Imaging (MRI)
Time frame: 2 years
This measure is the number of subjects experiencing a recurrence of the primary lesion as assessed by MRI.
6 secondary outcomes
Musculoskeletal Tumor Rating Scale (MSTS) Score
Time frame: Baseline, prior to surgery and 24 months after surgery
Disease-free Survival
Time frame: 2 Years
Overall Survival
Time frame: 2 Years
Radiologic Changes Due to Hypofractionated Radiation.
Time frame: 4 weeks after radiation therapy
Pathologic Changes Due to Hypofractionated Radiation.
Time frame: 2 weeks after surgery
Treatment-related Necrosis and Fibrosis
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35647402Bedi M, Singh R, Charlson JA, Kelly T, Johnstone C, Wooldridge A, Hackbarth DA, Moore N, Neilson JC, King DM. Is 5 the New 25? Long-Term Oncologic Outcomes From a Phase II, Prospective, 5-Fraction Preoperative Radiation Therapy Trial in Patients With Localized Soft Tissue Sarcoma. Adv Radiat Oncol. 2022 Jan 25;7(3):100850. doi: 10.1016/j.adro.2021.100850. eCollection 2022 May-Jun.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ciani Ellison, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated Radiation Therapy in people with Soft Tissue Sarcoma, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Disease Control Assessed by Physical Examination (time frame: 2 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02634710, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.