NCT07257523

Carbon Ion Radiotherapy in Frail Patients With Pancreatic Cancer

Carbon Ion Radiotherapy in Frail Patients With Pancreatic Cancer: A Prospective Phase II Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

"This prospective, single-arm phase II study evaluates the efficacy and safety of carbon ion radiotherapy in frail patients with non-metastatic pancreatic cancer who are not eligible for surgery or systemic chemotherapy due to a Clinical Frailty Scale (CFS) score ≥4 or significant medical comorbidities. carbon ion radiotherapy provides superior dose distribution and higher biological effectiveness compared with conventional X-ray radiotherapy, offering a potentially effective treatment option for this clinically vulnerable population. Participants will undergo baseline evaluations including imaging (CT/MRI/PET-CT), laboratory tests, tumor markers, frailty assessment, and quality-of-life questionnaires (EORTC QLQ-C30 and FACT-Hep). Carbon ion radiotherapy will be delivered using 4D-CT-based planning, with either 55.2 Gy (RBE) in 12 fractions or 40-48 Gy (RBE) in 4 fractions. Target volumes include the primary tumor and high-risk peripancreatic regions, while organs-at-risk such as the stomach, duodenum, bowel, liver, kidneys, and spinal cord follow strict dose constraints. Weekly on-treatment assessments will monitor acute toxicity using CTCAE v5.0, and adaptive planning will be performed if needed. Post-treatment follow-up will occur at 1-3 months and every 3-6 months thereafter for up to 2 years, including imaging, toxicity evaluation, tumor marker assessment, and repeated QOL surveys. The primary endpoint is overall survival. Secondary endpoints include progression-free survival, local control, treatment-related toxicity, quality of life, and tumor marker changes. Survival analyses will use Kaplan-Meier and Cox regression methods, and quality-of-life and toxicity outcomes will be summarized descriptively.

Conditions

• Pancreatic Neoplasm

Interventions

Type	Name	Description
OTHER	Carbon Ion Radiotherapy	Carbon ion radiotherapy is delivered with two possible regimens: 55.2 Gy in 12 fractions over 3 weeks or 40-48 Gy in 4 fractions over 1 week. Treatment planning is performed using contrast-enhanced CT and 4D-CT to assess respiratory motion. Target volumes include the gross tumor volume and high-risk peripancreatic regions, while organs at risk (stomach, duodenum, bowel, liver, kidneys, spinal cord) follow strict dose constraints. Treatments are delivered once daily for the 12-fraction regimen or on alternate days for the 4-fraction regimen. Adaptive planning may be applied if weekly evaluation CT identifies anatomic changes. Acute and late toxicities are monitored throughout treatment using CTCAE v5.0.

Timeline

• Start date: 2025-09-23
• Primary completion: 2027-07-01
• Completion: 2029-07-01
• First posted: 2025-12-02
• Last updated: 2025-12-02

Locations

1 site across 1 country: South Korea