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

Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.

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.