Carbon Ion Radiotherapy in Frail Patients With Pancreatic Cancer

NCT07257523 | Recruiting Phase 2

• 1 other identifier: 4-2025-0681
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Neoplasm

Outcome Measures

Primary Outcomes (1)

• Overall survival in frail patients with pancreatic cancer receiving carbon ion radiotherapy

  Overall survival will be assessed from the date of treatment initiation to death from any cause. The study will determine whether carbon ion radiotherapy provides a clinically meaningful improvement in survival compared with historical outcomes in frail patients with pancreatic cancer who previously received only supportive care or conventional X-ray radiotherapy.

  Up to 2 years from the start of treatment

Secondary Outcomes (6)

• Progression-free survival

  Up to 2 years from the start of treatment

• Local control rate

  Up to 2 years from the start of treatment

• Quality of Life: EORTC QLQ-C30 Score

  Baseline, end of radiotherapy, and every 3-6 months up to 2 years

• Treatment-related toxicity

  During radiotherapy and every 3-6 months up to 2 years

• Tumor marker changes (CA 19-9, CEA)

  Baseline and every follow-up visit up to 2 years

Study Arms (1)

Carbon Ion Radiotherapy

EXPERIMENTAL

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 (GTV/CTV), and organ-at-risk dose constraints. Radiotherapy is administered with daily or alternate-day fractionation depending on the selected regimen.

Other: Carbon Ion Radiotherapy

Interventions

Carbon Ion Radiotherapy OTHER

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.

Carbon Ion Radiotherapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Heavy Ion Radiotherapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study with no blinding. All participants and investigators are aware of the assigned intervention.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a prospective, single-arm phase II clinical trial evaluating 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.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 2, 2025
• Study Start: September 23, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2029
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)