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Clinical Trials in China / NCT05424159
Recruiting Not applicable

Ablative Carbon Ion Radiotherapy With Pencil Beam Scanning for Locally Advanced Unresectable Pancreatic Cancer

NCT05424159 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Proton and Heavy Ion Center
Phase
Not applicable
Started
2022-07-01
Last updated
2023-12-07

Condition(s) studied

Pancreatic Cancer Non-resectable

Investigational drug(s) / intervention(s)

Carbon ion radiotherapy

Carbon ion radiotherapy: Patients with locally advanced unresectable pancreatic cancer without invasion of gastrointestinal tract will received ablative carbon ion radiotherapy. The prescription dose for primary pancreatic lesion, positive lymph node, and retroperitoneal high-risk recurrence area is 67.5 Gy (RBE weighted dose) in 15 fractions for 3 weeks; Pancreatic primary lesion and positive lymph node SIB to 75 Gy (RBE weighted dose) in 15 fractions for 3 weeks.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shanghai Proton and Heavy Ion Center Shanghai China Recruiting

More Shanghai Proton and Heavy Ion Center trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05424159 on ClinicalTrials.gov ↗ ← All trials in China