Carbon Ion Radiotherapy in Frail Patients With Pancreatic Cancer
Recruiting · NCT07257523 · Interventional (participants receive a specific treatment) · Lead sponsor: Yonsei University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
"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.
Who can take part
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 is running
1 location listed.
- Yonsei University Health System, Severance Hospital - Seoul, South Korea