Soft Tissue SarcomaPhase 2NCT06087861
5-Day Preoperative Radiation for Soft Tissue Sarcoma
A Phase 2 study testing External Beam Radiotherapy in people with Soft Tissue Sarcoma, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to examine the safety and efficacy of an abbreviated course of preoperative radiation, given over five days, for patients with soft tissue sarcoma of the extremity, trunk or retroperitoneum. This is in contrast to standard preoperative radiation, which is given over 25 days. 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?
- External Beam Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2023to Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Histologically confirmed soft tissue sarcoma of the extremity, trunk or retroperitoneum.
- Has been offered preoperative radiation and surgery as part of standard-of-care treatment
- Age ≥ 18
- KPS ≥ 70 or ECOG 0 to 2
- Life expectancy ≥ 6 months
- If a woman is of childbearing potential, a negative serum or urine pregnancy test must be documented.
- Ability to understand and the willingness to personally sign the written IRB approved informed consent document.
Who cannot join
- History of prior radiation to the area to be treated.
- Active use of other anti-cancer investigational agents.
- Planned use of concurrent chemotherapy, targeted therapy, or immunotherapy with radiation therapy (defined as the time interval starting 1 week before the first and last fraction of radiation therapy and surgery).
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Palo Alto, California, 94305
Alyssa Yauger, 650-498-5271, ayauger@stanford.edu
Aastha Dubey, 650-725-2084, adubey7@stanford.edu
About this study
Official title: Phase 2 5-Day Preoperative Radiation for Soft Tissue Sarcoma
The purpose of this study is to examine the safety and efficacy of an abbreviated course of preoperative radiation, given over five days, for patients with soft tissue sarcoma of the extremity, trunk or retroperitoneum. This is in contrast to standard preoperative radiation, which is given over 25 days.
- Conditions
- Soft Tissue Sarcoma
- Being tested
- External Beam Radiotherapy
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Beam RadiotherapyRadiation
Radiation will be delivered by external beam techniques to the tumor and areas of possible microscopic disease at a dose of 30 Gy divided into 5 equal fractions of 6 Gy (administered over a total of 5 to 10 business day
| Study group | Role | What they receive |
|---|---|---|
| External beam radiotherapy | Experimental | Patients will receive treatment with external beam radiotherapy at a total of 30 Gy delivered over five fractions delivered daily. Receives: Radiation: External Beam Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Complication Rate
Rate of post-operative complications.
Measured: 120 days after surgery
Secondary outcomes (1)
Local Recurrence Rate
Rate of local recurrence, including in-field, borderline and out-field recurrences
Measured: 2 years and 5 years after surgical resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start6 Oct 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anusha Kalbasi, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087861
- Sponsor's protocol ID
- IRB-71865
- Other IDs
- NCI-2024-00868
- Status last verified
- Jun 2026
- First submitted
- 11 Oct 2023
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 5-Day Preoperative Radiation for Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT06087861
- Acronym / sponsor ID
- IRB-71865
- Conditions
- Soft Tissue Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the safety and efficacy of an abbreviated course of preoperative radiation, given over five days, for patients with soft tissue sarcoma of the extremity, trunk or retroperitoneum. This is in contrast to standard preoperative radiation, which is given over 25 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| External beam radiotherapy | Experimental | Radiation: External Beam RadiotherapyPatients will receive treatment with external beam radiotherapy at a total of 30 Gy delivered over five fractions delivered daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed soft tissue sarcoma of the extremity, trunk or retroperitoneum.
- Has been offered preoperative radiation and surgery as part of standard-of-care treatment
- Age ≥ 18
- KPS ≥ 70 or ECOG 0 to 2
- Life expectancy ≥ 6 months
Key exclusion criteria (4 listed)
- History of prior radiation to the area to be treated.
- Active use of other anti-cancer investigational agents.
- Planned use of concurrent chemotherapy, targeted therapy, or immunotherapy with radiation therapy (defined as the time interval starting 1 week before the first and last fraction of radiation therapy and surgery).
- Pregnancy.
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 |
|---|---|---|
| External Beam RadiotherapyRadiation will be delivered by external beam techniques to the tumor and areas of possible microscopic disease at a dose of 30 Gy divided into 5 equal fractions of 6 Gy (administered over a total of 5 to 10 business day | Radiation | External beam radiotherapy |
Primary outcome
Post-operative Complication Rate
Time frame: 120 days after surgery
Rate of post-operative complications.
1 secondary outcome
Local Recurrence Rate
Time frame: 2 years and 5 years after surgical resection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
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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.
Anusha Kalbasi, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing External Beam Radiotherapy in people with Soft Tissue Sarcoma, run by Stanford University 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 7 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 10 Jun 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alyssa Yauger (650-498-5271, ayauger@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative Complication Rate (time frame: 120 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2026; AzTrials last refreshed its copy on 30 Oct 2026.