Carbon Ion Radiotherapy in Frail Patients With Pancreatic Cancer
ConditionPancreatic Neoplasm
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20+
SponsorYonsei University
About this trial
"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
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
Carbon Ion Radiotherapy
Other interventionCarbon 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.
Treatment groups
33 Participants
are divided into 1 treatment groupGroup A: Carbon Ion RadiotherapyExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Up to 2 years from the start of treatmentSecondary outcomes
1
Progression-free survival
Progression-free survival will be measured from the start of carbon ion radiotherapy to radiologic tumor progression or death from any cause, whichever occurs first.
Time frame
Up to 2 years from the start of treatment2
Local control rate
Local control will be assessed through serial CT, MRI, or PET-CT imaging to determine the absence of local tumor progression within the irradiated region.
Time frame
Up to 2 years from the start of treatment3
Quality of Life: EORTC QLQ-C30 Score
Quality of life will be assessed using the EORTC QLQ-C30 questionnaire. The score ranges from 0 to 100. Higher scores indicate a higher response level (or better functioning/worse symptom, depending on the scale).
Time frame
Baseline, end of radiotherapy, and every 3-6 months up to 2 years4
Treatment-related toxicity
Acute and late toxicities will be recorded and graded according to CTCAE version 5.0 to evaluate the safety profile of carbon ion radiotherapy in frail pancreatic cancer patients.
Time frame
During radiotherapy and every 3-6 months up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov