SarcomaPhase 2neoSFRT-SARCNCT07501026
Preoperative Spatially Fractionated Radiation Therapy (SFRT) in Soft Tissue Sarcoma (neoSFRT-SARC)
A Phase 2 study testing SFRT in people with Sarcoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this prospective, single-arm, phase II trial is to evaluate whether a preoperative regimen combining spatially fractionated radiation therapy (SFRT) with subsequent surgery can improve outcomes in patients with large (≥5 cm) limb/trunk soft tissue sarcoma (STS). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sarcoma
- What is being tested?
- SFRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 16 Mar 2026to 16 Mar 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine
Hangzhou, Zhejiang, 310000
Ting Zhang, phD, 057187783521, zezht@zju.edu.cn
zezht@zju.edu.cn
About this study
Official title: A Phase II Prospective Study of Preoperative Spatially Fractionated Radiation Therapy (SFRT) in Soft Tissue Sarcoma (neoSFRT-SARC)
The goal of this prospective, single-arm, phase II trial is to evaluate whether a preoperative regimen combining spatially fractionated radiation therapy (SFRT) with subsequent surgery can improve outcomes in patients with large (≥5 cm) limb/trunk soft tissue sarcoma (STS). Currently, there is a lack of standardized SFRT-based protocols for operable or borderline-resectable large STS, and optimal dose-fractionation schedules, timing to surgery, differential efficacy by resectability status, and the induced systemic immune response remain undefined. Patients will receive 5 fractions of SFRT to the primary tumor, followed by definitive surgery. The main questions are:
- Can this SFRT-first approach increase the 1-year disease-free survival (DFS) compared with historical controls?
- What are the pathologic complete response (pCR) rate, overall survival (OS), and treatment-related safety profile?
- What immune mechanisms are engaged by SFRT, as reflected by dynamic changes in peripheral immune cell subsets and cytokines? Participants will undergo SFRT, then surgery, with serial blood sampling for immune monitoring.
Read the detailed description
For localized STS, surgery combined with radiotherapy is the standard of care. Preoperative radiotherapy can reduce tumor volume, facilitate resection, and lower recurrence risk. However, two major challenges remain: (1) radioresistance-STS is generally radioresistant, especially in bulky tumors; pivotal studies (e.g., RTOG 0630) report pathologic complete response (pCR) rates below 20% with conventional fractionation; (2) limited local control in unresectable cases-historical data show 5-year local control below 10% for tumors >10 cm treated with definitive radiotherapy alone.
Spatially fractionated radiation therapy (SFRT) delivers high-dose peaks within the tumor while maintaining lower-dose valleys, creating a non-uniform dose distribution that may enhance tumor kill, potentially trigger systemic antitumor immunity, and spare adjacent normal tissues. Recent retrospective data from Mayo Clinic (2024) demonstrated that in advanced, unresectable sarcomas, SFRT followed by conventional external-beam radiotherapy achieved 1-year local control of 82% and symptom relief in 60%, with acceptable toxicity. These promising results support prospective evaluation of SFRT in the preoperative setting for operable or borderline-resectable large STS.
Eligible patients will receive SFRT to the primary tumor in 5 fractions, followed by definitive surgery. The primary endpoint is 1-year disease-free survival (DFS). Secondary endpoints include pCR rate, overall survival (OS), and safety assessed by CTCAE v5.0. Exploratory objectives involve longitudinal monitoring of peripheral blood immune cell subsets (e.g., CD8⁺, CD4⁺, Treg cells) and cytokines (e.g., IFN-γ, TNF-α) to characterize SFRT-induced systemic immune modulation and identify potential biomarkers of response.
- Conditions
- Sarcoma
- Being tested
- SFRT
- Keywords
- Spatially Fractionated Radiation Therapy (SFRT)
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SFRTRadiation
- Preoperative SFRT: The prescribed dose is 20 Gy in 5 fractions, with lattice dose of 66.7Gy in 5 fractions.
- Surgery: Approximately one week after completion of SFRT, tumor resectability is reassessed. Patients who achieve sufficient tumor response undergo definitive surgical resection. Those who remain unsuitable for surgery after SFRT will receive alternative treatment per standard of care.
- Translational immune monitoring: Peripheral blood samples are collected at baseline, one week post-SFRT, and at 1, 3, 6, and 12 months post-treatment for exploratory analysis of immune cell subsets (e.g., CD8⁺ T cells) and cytokine profiles (e.g., IFN-γ, TNF-α), aimed at characterizing SFRT-induced systemic immune modulation.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative SFRT | Experimental | SFRT Administration: All patients will first receive preoperative SFRT. Regimen: Total dose PTV 66.7 (lattice) / 20 Gy, delivered in 5 fractions (the fractionation pattern will be individually optimized based on tumor location and adjacent organs to ensure that doses to critical structures remain within safe limits). Receives: Radiation: SFRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year Disease-Free Survival (DFS)
DFS defined as the time from enrollment to the first occurrence of local recurrence, regional recurrence, distant metastasis, or death from any cause, whichever occurs first. Patients who are alive and disease-free at 1 year are censored at their last disease assessment.
Measured: 1 year post-treatment
Secondary outcomes (3)
Pathologic Complete Response (pCR) Rate
Proportion of patients with no viable residual tumor cells in the resected primary tumor specimen and regional lymph nodes (if sampled) following preoperative SFRT and surgery, assessed by central pathology review.
Measured: At the time of surgery (approximately 1 week after SFRT)
Overall Survival (OS)
Time from enrollment to death from any cause. Patients alive at the last follow-up are censored.
Measured: Up to 3 years (duration of study follow-up)
Safety and Tolerability
Incidence, severity, and attribution of adverse events (AEs) and serious adverse events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Events include radiotherapy-related skin reactions, surgical complications, and systemic toxicities.
Measured: From SFRT initiation through 30 days after surgery (or longer for serious events)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start16 Mar 2026
- Primary completion16 Mar 2028 (estimated)
- Study completion16 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- 22 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501026
- Sponsor's protocol ID
- Y2026-0131
- Acronym
- neoSFRT-SARC
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Prospective Study of Preoperative Spatially Fractionated Radiation Therapy (SFRT) in Soft Tissue Sarcoma (neoSFRT-SARC)
- ClinicalTrials.gov ID
- NCT07501026
- Acronym / sponsor ID
- neoSFRT-SARC / Y2026-0131
- Conditions
- Sarcoma
- Keywords
- Spatially Fractionated Radiation Therapy (SFRT)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 16 Mar 2028 (estimated)
- Study completion
- 16 Mar 2029 (estimated)
- First posted
- 30 Mar 2026 (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 goal of this prospective, single-arm, phase II trial is to evaluate whether a preoperative regimen combining spatially fractionated radiation therapy (SFRT) with subsequent surgery can improve outcomes in patients with large (≥5 cm) limb/trunk soft tissue sarcoma (STS). Currently, there is a lack of standardized SFRT-based protocols for operable or borderline-resectable large STS, and optimal dose-fractionation schedules, timing to surgery, differential efficacy by resectability status, and the induced systemic immune response remain undefined. Patients will receive 5 fractions of SFRT to the primary tumor, followed by definitive surgery. The main questions are:
- Can this SFRT-first approach increase the 1-year disease-free survival (DFS) compared with historical controls?
- What are the pathologic complete response (pCR) rate, overall survival (OS), and treatment-related safety profile?
- What immune mechanisms are engaged by SFRT, as reflected by dynamic changes in peripheral immune cell subsets and cytokines? Participants will undergo SFRT, then surgery, with serial blood sampling for immune monitoring.
Detailed description
For localized STS, surgery combined with radiotherapy is the standard of care. Preoperative radiotherapy can reduce tumor volume, facilitate resection, and lower recurrence risk. However, two major challenges remain: (1) radioresistance-STS is generally radioresistant, especially in bulky tumors; pivotal studies (e.g., RTOG 0630) report pathologic complete response (pCR) rates below 20% with conventional fractionation; (2) limited local control in unresectable cases-historical data show 5-year local control below 10% for tumors >10 cm treated with definitive radiotherapy alone.
Spatially fractionated radiation therapy (SFRT) delivers high-dose peaks within the tumor while maintaining lower-dose valleys, creating a non-uniform dose distribution that may enhance tumor kill, potentially trigger systemic antitumor immunity, and spare adjacent normal tissues. Recent retrospective data from Mayo Clinic (2024) demonstrated that in advanced, unresectable sarcomas, SFRT followed by conventional external-beam radiotherapy achieved 1-year local control of 82% and symptom relief in 60%, with acceptable toxicity. These promising results support prospective evaluation of SFRT in the preoperative setting for operable or borderline-resectable large STS.
Eligible patients will receive SFRT to the primary tumor in 5 fractions, followed by definitive surgery. The primary endpoint is 1-year disease-free survival (DFS). Secondary endpoints include pCR rate, overall survival (OS), and safety assessed by CTCAE v5.0. Exploratory objectives involve longitudinal monitoring of peripheral blood immune cell subsets (e.g., CD8⁺, CD4⁺, Treg cells) and cytokines (e.g., IFN-γ, TNF-α) to characterize SFRT-induced systemic immune modulation and identify potential biomarkers of response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative SFRT | Experimental | Radiation: SFRTSFRT Administration: All patients will first receive preoperative SFRT. Regimen: Total dose PTV 66.7 (lattice) / 20 Gy, delivered in 5 fractions (the fractionation pattern will be individually optimized based on tumor location and adjacent organs to ensure that doses to critical structures remain within safe limits). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (9 listed)
- 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:
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 |
|---|---|---|
| SFRT1. Preoperative SFRT: The prescribed dose is 20 Gy in 5 fractions, with lattice dose of 66.7Gy in 5 fractions. 2. Surgery: Approximately one week after completion of SFRT, tumor resectability is reassessed. Patients who achieve sufficient tumor response undergo definitive surgical resection. Those who remain unsuitable for surgery after SFRT will receive alternative treatment per standard of care. 3. Translational immune monitoring: Peripheral blood samples are collected at baseline, one week post-SFRT, and at 1, 3, 6, and 12 months post-treatment for exploratory analysis of immune cell subsets (e.g., CD8⁺ T cells) and cytokine profiles (e.g., IFN-γ, TNF-α), aimed at characterizing SFRT-induced systemic immune modulation. | Radiation | Preoperative SFRT |
Primary outcome
1-year Disease-Free Survival (DFS)
Time frame: 1 year post-treatment
DFS defined as the time from enrollment to the first occurrence of local recurrence, regional recurrence, distant metastasis, or death from any cause, whichever occurs first. Patients who are alive and disease-free at 1 year are censored at their last disease assessment.
3 secondary outcomes
Pathologic Complete Response (pCR) Rate
Time frame: At the time of surgery (approximately 1 week after SFRT)
Overall Survival (OS)
Time frame: Up to 3 years (duration of study follow-up)
Safety and Tolerability
Time frame: From SFRT initiation through 30 days after surgery (or longer for serious events)
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 30 Mar 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.
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 SFRT in people with Sarcoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 8 inclusion and 9 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 30 Mar 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 China. 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 Ting Zhang, phD. (+86-571-87783521, zezht@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year Disease-Free Survival (DFS) (time frame: 1 year post-treatment). 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 30 Mar 2026.