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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Phase I: Incidence of Dose-Limiting Toxicities (DLTs)
研究概览
简要总结
"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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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) ≥
- •Adequate organ function (including hematologic, hepatic, and renal function) suitable for radiotherapy and surgery.
- •Voluntarily provided written informed consent.
排除标准
- •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.
结局指标
主要结局
Phase I: Incidence of Dose-Limiting Toxicities (DLTs)
时间窗: 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
时间窗: 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.
次要结局
- Local Control and Progression-Free Survival(From date of surgery to 12 months postoperatively)
- Overall Survival(From initiation of CIRT to 12 months postoperatively)
- Incidence of Acute Treatment-Related Toxicities(From initiation of CIRT to 30 days after surgery)
- Surgery Feasibility and Completion Rate(From completion of CIRT to 30 days after surgery)
- Pathological Tumor Response Rate(At surgical specimen evaluation (6-8 weeks after CIRT))
- R0 Resection Rate(At surgery (6-8 weeks after CIRT))
- Quality of Life (EORTC QLQ-C30)(Baseline, post-CIRT, and 3, 6, and 12 months after surgery)
- Body Composition Change (InBody Analysis) : Skeletal-Muscle Mass Change(Baseline, post-CIRT, and 3, 6, and 12 months after surgery)
- Body Composition Change (InBody Analysis) :Body-Fat Composition Change(Baseline, post-CIRT, and 3, 6, and 12 months after surgery)