Soft Tissue SarcomaSARCOMA-01NCT07250334
Prospective Phase I/II Study Evaluating the Safety and Efficacy of Preoperative Carbon Ion Radiotherapy in Patients With Soft Tissue Sarcoma : The SARCOMA-01 Trial by the Severance sARCOma Multidisciplinary Team
A study testing Carbon-Ion Radiotherapy (CIRT) in people with Soft Tissue Sarcoma, run by Yonsei University at 1 site in South Korea.
Trial summary
"This prospective, single-institution Phase I/II clinical trial investigates the safety, feasibility, and preliminary efficacy of preoperative carbon-ion radiotherapy (CIRT) for patients with resectable soft tissue sarcoma. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- Carbon-Ion Radiotherapy (CIRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2025to Sep 2028
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 19 years or older.
- Histologically confirmed soft tissue sarcoma deemed suitable for curative resection.
- Determined by the Yonsei Cancer Center sarcoma multidisciplinary team that preoperative carbon-ion radiotherapy followed by surgery is appropriate, considering tumor histologic subtype, size, and location.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 or Karnofsky Performance Status (KPS) ≥ 70.
- Adequate organ function (including hematologic, hepatic, and renal function) suitable for radiotherapy and surgery.
- Voluntarily provided written informed consent.
Who cannot join
- Presence of distant metastases.
- Inability to plan carbon-ion radiotherapy due to metallic implants or other factors at the tumor site.
- History of prior radiotherapy to the same anatomical region.
- Presence of other serious medical conditions or active infections that, in the investigator's judgment, could interfere with study participation.
- Presence of active implanted electronic devices (e.g., pacemaker or defibrillator) without established safety for carbon-ion radiotherapy.
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Yonsei Cancer Center, Yonsei University College of Medicine, Yonsei University Health System
Seoul
About this study
"This prospective, single-institution Phase I/II clinical trial investigates the safety, feasibility, and preliminary efficacy of preoperative carbon-ion radiotherapy (CIRT) for patients with resectable soft tissue sarcoma. Given the radioresistant nature of sarcomas and the limitations of photon-based preoperative radiotherapy-particularly high wound complication rates-CIRT is expected to enhance local tumor control while minimizing treatment-related toxicity and surgical morbidity.
The trial consists of an initial dose-escalation phase (phase 1) to identify an optimal and tolerable dose level, followed by an expansion phase (phase 2) assessing the feasibility of completing both CIRT and surgery without major wound complications. CIRT is delivered in eight fractions over two weeks, with surgery planned 6-8 weeks after radiotherapy.
Primary endpoints include the incidence of grade 3-5 post-operative wound complications within 120 days and overall treatment completion. Secondary endpoints include pathological response, surgical outcomes, local control, progression-free survival, overall survival, and patient-reported quality of life. All participants will be followed for at least 12 months postoperatively to evaluate safety and long-term outcomes.
- Conditions
- Soft Tissue Sarcoma
- Being tested
- Carbon-Ion Radiotherapy (CIRT)
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon-Ion Radiotherapy (CIRT)Radiation
Participants receive preoperative CIRT as the investigational intervention, delivered in 8 fractions, once daily, four times per week. In Phase I, three dose levels (DL1: 32.0 GyE, DL2: 34.0 GyE, DL3: 36.0 GyE) are evaluated using a 3+3 dose-escalation design to determine the recommended Phase II dose (RP2D). Three patients are initially enrolled per dose level, expanded to six if dose-limiting toxicities occur. In Phase II, all participants receive CIRT at the RP2D following a Simon's two-stage design (Stage I: 20 patients; Stage II: 22 additional if criteria met). Treatment uses fixed-beam or rotating gantry techniques. Post-treatment imaging (CT or MRI) is performed 4-6 weeks after CIRT, followed by surgical resection 6-8 weeks post-radiotherapy. All participants are followed for at least 12 months after surgery to assess postoperative wound complications, treatment completion, and overall outcomes.
| Study group | Role | What they receive |
|---|---|---|
| CIRT Group | Experimental | Phase I (Dose-Escalation) Participants in the Phase I cohort will receive preoperative CIRT using a dose-escalation design to identify an optimal tolerated dose. Three dose levels are evaluated-32.0, 34.0, and 36.0 GyE/8 fractions-delivered in 2 weeks (4 fr/week). Surgical resection is performed 6-8 weeks after CIRT, followed by postoperative evaluation of wound healing, toxicity, and surgical outcomes.
Phase II (Feasibility and Safety Evaluation) All enrolled patients will receive preoperative CIRT at the optimal dose determined in Phase I. The regimen consists of 8 fractions (4 fr/week), followed by surgical resection 6-8 weeks later. Postoperative assessments focus on feasibility and safety, particularly grade 3-5 wound complications within 120 days after surgery. Secondary analyses include pathological response, R0 resection rate, local control, survival, and quality of life. Participants are followed for at least 12 months to assess long-term safety and efficacy. Receives: Radiation: Carbon-Ion Radiotherapy (CIRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Incidence of Dose-Limiting Toxicities (DLTs)
To evaluate the safety and tolerability of preoperative CIRT and identify the optimal tolerated dose level. DLTs are defined as grade ≥3 toxicities, including severe wound complications, prolonged hospitalization, or significant treatment delay, assessed according to CTCAE version 5.0.
Measured: From initiation of CIRT to 30 days after surgery
Phase II: Proportion of Patients Completing Both CIRT and Surgery Without Grade 3-5 Postoperative Wound Complications or Serious Adverse Events
To determine the clinical feasibility and safety of completing preoperative CIRT followed by surgical resection without major wound-healing complications or treatment-related serious adverse events (SAEs). The endpoint represents the proportion of patients achieving treatment completion without grade 3-5 wound complications or other SAEs within 120 days postoperatively.
Measured: From initiation of CIRT to 120 days after surgery
Secondary outcomes (9)
Incidence of Acute Treatment-Related Toxicities
To record and grade all acute adverse events associated with preoperative carbon-ion radiotherapy using CTCAE v5.0 criteria to characterize the overall safety profile at each dose level.
Measured: From initiation of CIRT to 30 days after surgery
Surgery Feasibility and Completion Rate
To assess the proportion of participants who successfully undergo and complete surgical resection following preoperative CIRT without protocol deviation or treatment interruption.
Measured: From completion of CIRT to 30 days after surgery
Pathological Tumor Response Rate
To determine the rate of pathological tumor regression or necrosis in resected specimens following preoperative CIRT, based on standardized histologic grading criteria.
Measured: At surgical specimen evaluation (6-8 weeks after CIRT)
R0 Resection Rate
To evaluate the proportion of patients achieving microscopically margin-negative (R0) resection after preoperative CIRT, reflecting its impact on surgical resectability.
Measured: At surgery (6-8 weeks after CIRT)
Local Control and Progression-Free Survival
To estimate 1-year local control and progression-free survival using Kaplan-Meier analysis as measures of preliminary efficacy.
Measured: From date of surgery to 12 months postoperatively
Overall Survival
To evaluate 12-month overall survival as an exploratory efficacy endpoint of preoperative CIRT.
Measured: From initiation of CIRT to 12 months postoperatively
Quality of Life (EORTC QLQ-C30)
To assess longitudinal changes in patient-reported quality of life using the EORTC QLQ-C30 questionnaire throughout treatment and follow-up.
Measured: Baseline, post-CIRT, and 3, 6, and 12 months after surgery
Body Composition Change (InBody Analysis) : Skeletal-Muscle Mass Change
Unit of Measure: kg
Measured: Baseline, post-CIRT, and 3, 6, and 12 months after surgery
Body Composition Change (InBody Analysis) :Body-Fat Composition Change
Body-Fat Composition Change
Measured: Baseline, post-CIRT, and 3, 6, and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study startNov 2025 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (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 Yonsei 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250334
- Sponsor's protocol ID
- 4-2025-1025
- Acronym
- SARCOMA-01
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Phase I/II Study Evaluating the Safety and Efficacy of Preoperative Carbon Ion Radiotherapy in Patients With Soft Tissue Sarcoma : The SARCOMA-01 Trial by the Severance sARCOma Multidisciplinary Team
- ClinicalTrials.gov ID
- NCT07250334
- Acronym / sponsor ID
- SARCOMA-01 / 4-2025-1025
- Conditions
- Soft Tissue Sarcoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 26 Nov 2025 (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.
"This prospective, single-institution Phase I/II clinical trial investigates the safety, feasibility, and preliminary efficacy of preoperative carbon-ion radiotherapy (CIRT) for patients with resectable soft tissue sarcoma. Given the radioresistant nature of sarcomas and the limitations of photon-based preoperative radiotherapy-particularly high wound complication rates-CIRT is expected to enhance local tumor control while minimizing treatment-related toxicity and surgical morbidity.
The trial consists of an initial dose-escalation phase (phase 1) to identify an optimal and tolerable dose level, followed by an expansion phase (phase 2) assessing the feasibility of completing both CIRT and surgery without major wound complications. CIRT is delivered in eight fractions over two weeks, with surgery planned 6-8 weeks after radiotherapy.
Primary endpoints include the incidence of grade 3-5 post-operative wound complications within 120 days and overall treatment completion. Secondary endpoints include pathological response, surgical outcomes, local control, progression-free survival, overall survival, and patient-reported quality of life. All participants will be followed for at least 12 months postoperatively to evaluate safety and long-term outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CIRT Group | Experimental | Radiation: Carbon-Ion Radiotherapy (CIRT)Phase I (Dose-Escalation) Participants in the Phase I cohort will receive preoperative CIRT using a dose-escalation design to identify an optimal tolerated dose. Three dose levels are evaluated-32.0, 34.0, and 36.0 GyE/8 fractions-delivered in 2 weeks (4 fr/week). Surgical resection is performed 6-8 weeks after CIRT, followed by postoperative evaluation of wound healing, toxicity, and surgical outcomes. Phase II (Feasibility and Safety Evaluation) All enrolled patients will receive preoperative CIRT at the optimal dose determined in Phase I. The regimen consists of 8 fractions (4 fr/week), followed by surgical resection 6-8 weeks later. Postoperative assessments focus on feasibility and safety, particularly grade 3-5 wound complications within 120 days after surgery. Secondary analyses include pathological response, R0 resection rate, local control, survival, and quality of life. Participants are followed for at least 12 months to assess long-term safety and efficacy. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 19 years or older.
- Histologically confirmed soft tissue sarcoma deemed suitable for curative resection.
- Determined by the Yonsei Cancer Center sarcoma multidisciplinary team that preoperative carbon-ion radiotherapy followed by surgery is appropriate, considering tumor histologic subtype, size, and location.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 or Karnofsky Performance Status (KPS) ≥ 70.
- Adequate organ function (including hematologic, hepatic, and renal function) suitable for radiotherapy and surgery.
Key exclusion criteria (6 listed)
- Presence of distant metastases.
- Inability to plan carbon-ion radiotherapy due to metallic implants or other factors at the tumor site.
- History of prior radiotherapy to the same anatomical region.
- Presence of other serious medical conditions or active infections that, in the investigator's judgment, could interfere with study participation.
- Presence of active implanted electronic devices (e.g., pacemaker or defibrillator) without established safety for carbon-ion radiotherapy.
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 |
|---|---|---|
| Carbon-Ion Radiotherapy (CIRT)Participants receive preoperative CIRT as the investigational intervention, delivered in 8 fractions, once daily, four times per week. In Phase I, three dose levels (DL1: 32.0 GyE, DL2: 34.0 GyE, DL3: 36.0 GyE) are evaluated using a 3+3 dose-escalation design to determine the recommended Phase II dose (RP2D). Three patients are initially enrolled per dose level, expanded to six if dose-limiting toxicities occur. In Phase II, all participants receive CIRT at the RP2D following a Simon's two-stage design (Stage I: 20 patients; Stage II: 22 additional if criteria met). Treatment uses fixed-beam or rotating gantry techniques. Post-treatment imaging (CT or MRI) is performed 4-6 weeks after CIRT, followed by surgical resection 6-8 weeks post-radiotherapy. All participants are followed for at least 12 months after surgery to assess postoperative wound complications, treatment completion, and overall outcomes. | Radiation | CIRT Group |
Primary outcome
Phase I: Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: From initiation of CIRT to 30 days after surgery
To evaluate the safety and tolerability of preoperative CIRT and identify the optimal tolerated dose level. DLTs are defined as grade ≥3 toxicities, including severe wound complications, prolonged hospitalization, or significant treatment delay, assessed according to CTCAE version 5.0.
Phase II: Proportion of Patients Completing Both CIRT and Surgery Without Grade 3-5 Postoperative Wound Complications or Serious Adverse Events
Time frame: From initiation of CIRT to 120 days after surgery
To determine the clinical feasibility and safety of completing preoperative CIRT followed by surgical resection without major wound-healing complications or treatment-related serious adverse events (SAEs). The endpoint represents the proportion of patients achieving treatment completion without grade 3-5 wound complications or other SAEs within 120 days postoperatively.
9 secondary outcomes
Incidence of Acute Treatment-Related Toxicities
Time frame: From initiation of CIRT to 30 days after surgery
Surgery Feasibility and Completion Rate
Time frame: From completion of CIRT to 30 days after surgery
Pathological Tumor Response Rate
Time frame: At surgical specimen evaluation (6-8 weeks after CIRT)
R0 Resection Rate
Time frame: At surgery (6-8 weeks after CIRT)
Local Control and Progression-Free Survival
Time frame: From date of surgery to 12 months postoperatively
Overall Survival
Time frame: From initiation of CIRT to 12 months postoperatively
Quality of Life (EORTC QLQ-C30)
Time frame: Baseline, post-CIRT, and 3, 6, and 12 months after surgery
Body Composition Change (InBody Analysis) : Skeletal-Muscle Mass Change
Time frame: Baseline, post-CIRT, and 3, 6, and 12 months after surgery
Body Composition Change (InBody Analysis) :Body-Fat Composition Change
Time frame: Baseline, post-CIRT, and 3, 6, and 12 months after surgery
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 26 Nov 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbon-Ion Radiotherapy (CIRT) in people with Soft Tissue Sarcoma, run by Yonsei University at 1 site in South Korea.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 26 Nov 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 South Korea. 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?
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?
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?
Phase I: Incidence of Dose-Limiting Toxicities (DLTs) (time frame: From initiation of CIRT to 30 days after surgery). 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?
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 26 Nov 2025.