Carbon ion radiotherapy for frail people with pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-arm Phase II trial delivers carbon ion radiotherapy to frail patients with histologically confirmed, non-metastatic pancreatic cancer who are ineligible for surgery or systemic chemotherapy due to a Clinical Frailty Scale (CFS) score ≥4 or significant comorbidities. Treatment planning uses 4D-CT and delivers either 55.2 Gy (RBE) in 12 fractions or 40–48 Gy (RBE) in 4 fractions to the primary tumor and high-risk peripancreatic regions while respecting strict organ-at-risk dose limits. Participants undergo baseline imaging, laboratory tests, tumor marker and frailty assessments, quality-of-life questionnaires, weekly on-treatment toxicity monitoring with CTCAE v5.0, and adaptive planning as needed. Follow-up includes imaging and QOL surveys at 1–3 months and then every 3–6 months for up to two years, with the primary endpoint of overall survival and secondary endpoints of progression-free survival, local control, toxicity, and quality of life.

Why it matters

Who can join: the full rules

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.

Where it's running

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.