Clinical trial · Interventional
Ablative Carbon Ion Radiotherapy With Pencil Beam Scanning for Locally Advanced Unresectable Pancreatic Cancer
Prospective Phase II Clinical Trial of Ablative Carbon Ion Radiotherapy With Pencil Beam Scanning Using Simultaneous Integrated Boost for Locally Advanced Unresectable Pancreatic Cancer
NCT05424159CI-TRIAL-00072042recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to investigate the clinical efficacy and safety of ablative carbon ion radiotherapy for locally advanced unresectable pancreatic cancer with pencil beam scanning and simultaneous integrated boost (SIB) technology.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer Non-resectable | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carbon ion radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with locally advanced unresectable pancreatic cancer
- description
- Patients with locally advanced unresectable pancreatic cancer without invasion of the gastrointestinal tract, cT4N0-2M0 Stage III (AJCC/UICC Version 8).
- interventionNames
- Radiation: Carbon ion radiotherapy
Primary outcomes (1)
- measure
- 2-year cumulative local regional progression rate (LRP)
- timeFrame
- From the date of the initiation of radiotherapy until the date of first documented occurrence of local regional progression, assessed up to 24 months.
- description
- LRP was defined as the percentage of patients with local disease progression (within irradiated area) in the intentional population.
Secondary outcomes (3)
- measure
- 2-year Overall survival (OS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Have the ability to sign the written informed consent; 2. Ductal adenocarcinoma of the pancreas confirmed by histopathology or cytopathology; 3. Distant metastasis was excluded by imaging assessment (PET-CT, cranial MRI), and was defined as locally advanced unresectable according to NCCN Guidelines Version 2022.1, that is, T4N0-2M0, Stage III (AJCC/UICC Version 8); 4. The maximum diameter of pancreatic primary lesion and positive lymph node ≤7cm; 5. Pancreas primary lesion or positive lymph node did not invade digestive tract (stomach, duodenum and small intestine); 6. Eastern Cooperative Oncology Group (ECOG) performance score 0-1; 7. Adequate bone marrow function (neutrophil count ≥1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥10.0g/dL); 8. Adequate liver function (total bilirubin \<1.5 times the upper limit of normal value, aminotransferase \<2.5 times the upper limit of normal value); 9. Adequate renal function (serum creatinine \<2mg/dL, or creatinine clearance \>50mL/min). Exclusion Criteria: 1. Multiple primary pancreatic lesions (\>1); 2. Tumor invaded the adjacent digestive tract; 3. Radiation therapy history; 4. Other local treatments history for pancreatic cancer, such as HIFU and irreversible electroporation; 5. The irradiation dose of organs at risk cannot reach the dose constraint; 6. Other malignant tumors history; 7. Inability to understand the purpose of treatment or unwillingness/inability to sign informed consent.
References
Publications (0)
Data not yet available
No reference posted for this study.