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New radiation combo aims to shrink sarcomas before surgery

NCT ID NCT07501026

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 22 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • 2nd Affiliated Hospital, School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310000, China

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