New radiation combo aims to shrink sarcomas before surgery
NCT ID NCT07501026
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial is testing whether a special type of radiation therapy (SFRT) given before surgery can improve outcomes for people with large soft tissue sarcomas (at least 5 cm) in the limbs or trunk. About 22 adults will receive 5 doses of SFRT, then have surgery about a week later. Researchers will track how many patients are cancer-free after one year, how well the tumor responds, and any side effects. Blood samples will also be taken to study how the immune system reacts.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- spatially fractionated radiation therapy (SFRT)
- What this could lead to
- If successful, this approach could improve disease-free survival and tumor response before surgery for large soft tissue sarcomas, potentially offering a new standard preoperative option.
- What could go wrong
- This is a small, early-phase (phase II) trial with only 22 participants, so results may not apply broadly. Radiation side effects and surgical complications are possible, and the benefit over current treatments is not yet proven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 22 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically confirmed soft tissue sarcoma of the extremity or trunk, with tumor size ≥5 cm in greatest dimension (by imaging or clinical examination). * Disease classified as operable or borderline-resectable as determined by the multidisciplinary tumor board. * Age ≥18 years at the time of consent. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Adequate organ function as defined by: Absolute neutrophil count ≥1.5 × 10⁹/L; Platelet count ≥100 × 10⁹/L; Hemoglobin ≥9.0 g/dL; Total bilirubin ≤1.5 × upper limit of normal (ULN) (or ≤3 × ULN in patients with Gilbert's syndrome); AST/ALT ≤2.5 × ULN; Creatinine clearance ≥50 mL/min (by Cockcroft-Gault or measured); * Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment and agree to use effective contraception during the study treatment period and for at least 3 months after the last study procedure. Men with partners of childbearing potential must agree to use effective contraception during the same period. * Willing and able to provide written informed consent and comply with all study procedures, including scheduled follow-up visits and blood sample collections. Exclusion Criteria: * Prior radiotherapy to the same anatomical site that would result in overlap of radiation fields. * Distant metastases at the time of enrollment (M1 disease). * Pregnancy or breastfeeding. * Active second malignancy requiring systemic therapy within the past 3 years, except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ. * Severe, active comorbidities including but not limited to: Uncontrolled infection requiring intravenous antibiotics; Decompensated heart failure (New York Heart Association Class III or IV); Myocardial infarction or unstable angina within 6 months; Severe chronic obstructive pulmonary disease or other conditions that would preclude safe radiotherapy or surgery. * Known hypersensitivity to radiation therapy procedures or inability to undergo required imaging (e.g., MRI contrast allergy not manageable with premedication). * Concurrent participation in another interventional clinical trial with an investigational agent within 30 days prior to enrollment. * Any condition that, in the opinion of the investigator, would compromise patient safety, interfere with study compliance, or preclude successful completion of the study procedures.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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2nd Affiliated Hospital, School of Medicine
RECRUITINGHangzhou, Zhejiang, 310000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Blood-Flow-Blocking drug stall a rare sarcoma?
- Can a dual immune antibody plus radiation shrink metastatic sarcoma?
- Can a new drug shrink advanced solid tumors?
- Can a coordinated care team reduce severe side effects in older cancer patients?
- Can repeated MRI scans reveal how tumors respond to radiation?
- Can a new antibody help the immune system fight Hard-to-Treat tumors?