NCT07257523RecruitingPhase 2
Carbon Ion Radiotherapy in Frail Patients With Pancreatic Cancer
Carbon Ion Radiotherapy in Frail Patients With Pancreatic Cancer: A Prospective Phase II Study
Source: ClinicalTrials.gov · Last updated 2 Dec 2025
Brief summary (registry, in English)
"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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 33 (estimated)
- First submitted
- 17 Nov 2025
- Start date
- 23 Sept 2025
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Yonsei University
- Diseases
- Pancreatic cancer
- NCT number
- NCT07257523
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 33
- From 23 Sept 2025 to the primary completion date, 31 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- 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.
Who the study is looking for
- \- 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.
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yonsei University Health System, Severance Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.