Carbon ion radiotherapy for frail people with pancreatic cancer
Carbon Ion Radiotherapy in Frail Patients With Pancreatic Cancer: A Prospective Phase II Study
This trial will try carbon ion radiotherapy as a treatment for people with non-metastatic pancreatic cancer who are too frail for surgery or standard chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Seoul) |
| Trial ID | NCT07257523 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults (≥19 years) with histologically confirmed, non-metastatic pancreatic cancer who are not eligible for surgery or systemic chemotherapy because of CFS ≥4 or significant comorbidities and who can provide informed consent and attend treatment at the study center.
Not a fit: Patients with distant metastases, active uncontrolled infections, severe organ dysfunction that prevents safe radiotherapy, pregnant or breastfeeding women, or those unable to comply with study procedures or follow-up are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could give frail patients better local tumor control and a chance for longer survival while avoiding the systemic side effects of chemotherapy.
How similar studies have performed: Carbon ion radiotherapy has shown promising local control in selected tumor types and in limited pancreatic cancer series, but randomized evidence—particularly in frail patient populations—is sparse.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Seoul
- Yonsei University Health System, Severance Hospital — Seoul, South Korea (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.