NCT07257523 Carbon Ion Radiotherapy in Frail Patients With Pancreatic Cancer
| NCT ID | NCT07257523 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Yonsei University |
| Condition | Pancreatic Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 33 participants |
| Start Date | 2025-09-23 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 33 participants in total. It began in 2025-09-23 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
"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.
Eligibility 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.
Frequently Asked Questions
Who can join the NCT07257523 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Pancreatic Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07257523 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07257523 currently recruiting?
Yes, NCT07257523 is actively recruiting participants. Visit ClinicalTrials.gov or contact Yonsei University to inquire about joining.
Where is the NCT07257523 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT07257523 clinical trial?
NCT07257523 is sponsored by Yonsei University. The trial plans to enroll 33 participants.