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

Обзор

"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.

Вмешательства

• Лучевая терапия 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

Первичные конечные точки

• Phase I: Incidence of Dose-Limiting Toxicities (DLTs) [Срок оценки: 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 [Срок оценки: From initiation of CIRT to 120 days after surgery]

Вторичные конечные точки (9)

• Incidence of Acute Treatment-Related Toxicities [Срок оценки: From initiation of CIRT to 30 days after surgery]
• Surgery Feasibility and Completion Rate [Срок оценки: From completion of CIRT to 30 days after surgery]
• Pathological Tumor Response Rate [Срок оценки: At surgical specimen evaluation (6-8 weeks after CIRT)]
• R0 Resection Rate [Срок оценки: At surgery (6-8 weeks after CIRT)]
• Local Control and Progression-Free Survival [Срок оценки: From date of surgery to 12 months postoperatively]
• Overall Survival [Срок оценки: From initiation of CIRT to 12 months postoperatively]
• Quality of Life (EORTC QLQ-C30) [Срок оценки: Baseline, post-CIRT, and 3, 6, and 12 months after surgery]
• Body Composition Change (InBody Analysis) : Skeletal-Muscle Mass Change [Срок оценки: Baseline, post-CIRT, and 3, 6, and 12 months after surgery]
• Body Composition Change (InBody Analysis) :Body-Fat Composition Change [Срок оценки: Baseline, post-CIRT, and 3, 6, and 12 months after surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Yonsei Cancer Center, Yonsei University College of Medicine, Yonsei University Health Syst — Seoul

Идентификаторы

NCT: NCT07250334 · 4-2025-1025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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