RecruitingPhase 2NCT07257523

Carbon Ion Radiotherapy in Frail Patients With Pancreatic Cancer

Carbon Ion Radiotherapy in Frail Patients With Pancreatic Cancer: A Prospective Phase II Study

Sponsor

Yonsei University

Enrollment

33 participants

Start Date

Sep 23, 2025

Study Type

INTERVENTIONAL

Conditions

Pancreatic Neoplasm

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

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study tests carbon ion radiotherapy — a more precise and powerful form of radiation — for frail or elderly patients with pancreatic cancer who are unable to tolerate surgery or standard chemotherapy due to their overall health status. **You may be eligible if...** - You have confirmed pancreatic cancer that has not spread to distant organs - You are not a candidate for surgery or chemotherapy because of frailty, significant other health conditions, or personal preference - You score 4 or higher on the Clinical Frailty Scale (meaning you are vulnerable or more dependent in daily activities) **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic) - You are healthy enough to tolerate standard surgery or chemotherapy - You have conditions that make radiation therapy unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERCarbon 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.

Locations(1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

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NCT07257523

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