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NCT Number: NCT07250334

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

"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.

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Key information

Conditions

Soft Tissue Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Sarcoma

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei Cancer Center, Yonsei University College of Medicine, Yonsei University Health System

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Incidence of Acute Treatment-Related Toxicities

    Time frame: From initiation of CIRT to 30 days after surgery

    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.

  2. Surgery Feasibility and Completion Rate

    Time frame: From completion of CIRT to 30 days after surgery

    To assess the proportion of participants who successfully undergo and complete surgical resection following preoperative CIRT without protocol deviation or treatment interruption.

  3. Pathological Tumor Response Rate

    Time frame: At surgical specimen evaluation (6-8 weeks after CIRT)

    To determine the rate of pathological tumor regression or necrosis in resected specimens following preoperative CIRT, based on standardized histologic grading criteria.

  4. R0 Resection Rate

    Time frame: At surgery (6-8 weeks after CIRT)

    To evaluate the proportion of patients achieving microscopically margin-negative (R0) resection after preoperative CIRT, reflecting its impact on surgical resectability.

  5. Local Control and Progression-Free Survival

    Time frame: From date of surgery to 12 months postoperatively

    To estimate 1-year local control and progression-free survival using Kaplan-Meier analysis as measures of preliminary efficacy.

  6. Overall Survival

    Time frame: From initiation of CIRT to 12 months postoperatively

    To evaluate 12-month overall survival as an exploratory efficacy endpoint of preoperative CIRT.

  7. Quality of Life (EORTC QLQ-C30)

    Time frame: Baseline, post-CIRT, and 3, 6, and 12 months after surgery

    To assess longitudinal changes in patient-reported quality of life using the EORTC QLQ-C30 questionnaire throughout treatment and follow-up.

  8. Body Composition Change (InBody Analysis) : Skeletal-Muscle Mass Change

    Time frame: Baseline, post-CIRT, and 3, 6, and 12 months after surgery

    Unit of Measure: kg

  9. Body Composition Change (InBody Analysis) :Body-Fat Composition Change

    Time frame: Baseline, post-CIRT, and 3, 6, and 12 months after surgery

    Body-Fat Composition Change

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Acronym: SARCOMA-01

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 26, 2025
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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