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Clinical Trials in South Korea / NCT07257523
Recruiting Phase 2

Carbon Ion Radiotherapy in Frail Patients With Pancreatic Cancer

NCT07257523 · tracked via the Priya Life Science South Korea tracker
Sponsor
Yonsei University
Phase
Phase 2
Started
2025-09-23
Last updated
2025-12-02

Condition(s) studied

Pancreatic Neoplasm

Investigational drug(s) / intervention(s)

Carbon Ion Radiotherapy

Carbon Ion Radiotherapy: Carbon ion radiotherapy is delivered with two possible regimens: 55.2 Gy in 12 fractions over 3 weeks or 40-48 Gy in 4 fractions over 1 week. Treatment planning is performed using contrast-enhanced CT and 4D-CT to assess respiratory motion. Target volumes include the gross tumor volume and high-risk peripancreatic regions, while organs at risk (stomach, duodenum, bowel, liver, kidneys, spinal cord) follow strict dose constraints. Treatments are delivered once daily for the 12-fraction regimen or on alternate days for the 4-fraction regimen. Adaptive planning may be applied if weekly evaluation CT identifies anatomic changes. Acute and late toxicities are monitored throughout treatment using CTCAE v5.0.

Study summary

"This prospective, single-arm phase II study aims to evaluate the efficacy and safety of carbon ion radiotherapy in frail patients with histologically confirmed, non-metastatic pancreatic cancer who are not eligible for surgery or systemic chemotherapy. Frail status is defined as a Clinical Frailty Scale (CFS) score ≥4 or the presence of significant medical comorbidities limiting aggressive treatment.

Carbon ion radiotherapy, known for its superior dose distribution and high linear energy transfer, may offer improved tumor control with acceptable toxicity in this vulnerable population. This study will assess overall survival, progression-free survival, local control, toxicity, and quality of life.

Eligibility

Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: \- Histologically confirmed pancreatic cancer without distant metastasis. Not eligible for surgery or systemic chemotherapy, defined as: Clinical Frailty Scale (CFS) score ≥ 4, or Significant medical comorbidities precluding standard treatment. Patients who decline surgery and chemotherapy after adequate counseling. Age ≥ 19 years. Able to provide written informed consent. Eligible and willing to receive carbon ion radiotherapy. Exclusion Criteria: * Age \< 19 years. Presence of distant metastasis at baseline imaging (CT/MRI/PET-CT). Active or uncontrolled infection that may interfere with treatment. Active bleeding or bleeding tendency requiring immediate medical intervention. Pregnant or breastfeeding women. Any condition that, in the investigator's judgment, makes participation unsafe or inappropriate (e.g., severe organ dysfunction preventing radiotherapy). Inability to comply with study procedures or follow-up schedule.

Primary outcome measure(s)

  • Overall survival in frail patients with pancreatic cancer receiving carbon ion radiotherapy — Up to 2 years from the start of treatment
    Overall survival will be assessed from the date of treatment initiation to death from any cause. The study will determine whether carbon ion radiotherapy provides a clinically meaningful improvement in survival compared with historical outcomes in frail patients with pancreatic cancer who previously received only supportive care or conventional X-ray radiotherapy.

Trial sites (1)

FacilityCityRegionStatus
Yonsei University Health System, Severance Hospital Seoul South Korea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07257523 on ClinicalTrials.gov ↗ ← All trials in South Korea