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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Carbon-Ion Radiotherapy (CIRT).
- Who it may be relevant to
- Registry conditions: Soft Tissue Sarcoma. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
"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.
Interventions
- Radiation 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
Primary outcome measures
- Phase I: Incidence of Dose-Limiting Toxicities (DLTs) [Time frame: 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 [Time frame: From initiation of CIRT to 120 days after surgery]
Secondary outcome measures (9)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Yonsei Cancer Center, Yonsei University College of Medicine, Yonsei University Health Syst — Seoul
Identifiers
NCT: NCT07250334 · 4-2025-1025