Actively Recruiting
Carbon Ion Radiotherapy in Frail Patients With Pancreatic Cancer: A Prospective Phase II Study
Led by Yonsei University · Updated on 2025-12-02
33
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of carbon ion radiotherapy in frail patients diagnosed with non-metastatic pancreatic cancer who cannot undergo surgery or systemic chemotherapy. Frailty is defined by a Clinical Frailty Scale score of 4 or higher or by significant medical conditions that limit aggressive treatments. This phase II study aims to assess the treatment's impact on overall survival, progression-free survival, tumor control, side effects, and quality of life. Participants will receive carbon ion radiotherapy delivered through one of two schedules: either 55.2 Gy over 12 fractions in 3 weeks or 40-48 Gy over 4 fractions in 1 week. Treatment planning uses advanced imaging techniques including 4D-CT to target the tumor and high-risk areas while protecting nearby organs such as the stomach, liver, and kidneys. Treatments are given daily or on alternate days depending on the chosen regimen, with weekly evaluations to adjust plans if needed. During the study, participants will undergo baseline imaging, laboratory tests, frailty assessments, and quality-of-life questionnaires. Follow-up visits occur 1 to 3 months after treatment and then every 3 to 6 months for up to 2 years, including imaging, toxicity monitoring, tumor marker checks, and repeated quality-of-life surveys. The main measure is overall survival over two years, with secondary outcomes including tumor control, treatment side effects, and quality of life changes.
CONDITIONS
Brief 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 at baseline imaging.
- Active or uncontrolled infection interfering with treatment.
- Active bleeding or bleeding tendency requiring immediate medical intervention.
- Pregnant or breastfeeding women.
- Any condition judged unsafe or inappropriate for participation by the investigator.
- Inability to comply with study procedures or follow-up schedule.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 1 to 3 weeks
Participants receive carbon ion radiotherapy delivered either as 55.2 Gy in 12 fractions over 3 weeks or 40-48 Gy in 4 fractions over 1 week. Treatment planning includes 4D-CT-based simulation, defined target volumes, and organ-at-risk dose constraints. Radiotherapy is administered daily or on alternate days depending on the regimen. Weekly on-treatment assessments monitor acute toxicity and adaptive planning may be applied if needed.
Weekly visits during treatment
Duration - Up to 2 years
After treatment, participants have follow-up visits including imaging, toxicity evaluation, tumor marker assessments, and quality-of-life surveys. Follow-up occurs at 1-3 months after treatment and every 3-6 months thereafter for up to 2 years to monitor treatment effects and overall health.
Visits at 1-3 months post-treatment and every 3-6 months thereafter
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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