Actively Recruiting
Carbon Ion Radiotherapy in Frail Patients With Pancreatic Cancer
Led by Yonsei University · Updated on 2025-12-02
33
Participants Needed
1
Research Sites
196 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Carbon Ion Radiotherapy in Frail Patients With Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed pancreatic cancer without distant metastasis
- Not eligible for surgery or systemic chemotherapy due to Clinical Frailty Scale score of 4 or higher or significant medical comorbidities
- Patients who decline surgery and chemotherapy after counseling
- Age 20 years or older
- Able to provide written informed consent
- Eligible and willing to receive carbon ion radiotherapy
You will not qualify if you...
- Age younger than 20 years
- Presence of distant metastasis on baseline imaging
- Active or uncontrolled infection interfering with treatment
- Active bleeding or bleeding tendency needing immediate medical care
- Pregnant or breastfeeding women
- Any condition making participation unsafe or inappropriate, such as severe organ dysfunction preventing radiotherapy
- Inability to follow study procedures or attend follow-up visits
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Yonsei University Health System, Severance Hospital
Seoul, South Korea
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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