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

Official title

Prospective Phase II Clinical Trial of Ablative Carbon Ion Radiotherapy With Pencil Beam Scanning Using Simultaneous Integrated Boost for Locally Advanced Unresectable Pancreatic Cancer

Overview

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.

Detailed description

The aim of this study is to investigate the clinical efficacy and safety of ablative carbon ion radiotherapy for locally advanced unresectable pancreatic cancer using pencil beam scanning and simultaneous integrated boost technology with respect to toxicity and tumor control. All enrolled patients will receive carbon ion radiotherapy for the primary pancreatic lesions, positive lymph nodes, and retroperitoneal high-risk recurrence areas. 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. The primary endpoint is 2-year cumulative local regional progression rate (LRP), and the secondary endpoint is to assess the overall survival (OS) and toxicities. Toxicity was assessed using the Common Adverse Event Evaluation Criteria (CTCAE) Version 5.0, and safety and toxicity will be assessed by clinical examination, laboratory examination, and imaging (including CT, MRI, and/or PET/CT).

Interventions

• Radiation 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.

Primary outcome measures

• 2-year cumulative local regional progression rate (LRP) [Time frame: From the date of the initiation of radiotherapy until the date of first documented occurrence of local regional progression, assessed up to 24 months.]

Secondary outcome measures (3)

• 2-year Overall survival (OS) [Time frame: From the date of diagnosis until the date of death from any cause, assessed up to 24 months.]
• Acute toxicity [Time frame: From the date of the initiation of radiotherapy until the date of 3 months after radiotherapy.]
• Late toxicity [Time frame: 3 months after radiotherapy.]

Eligibility criteria

Inclusion criteria

• Have the ability to sign the written informed consent;
• Ductal adenocarcinoma of the pancreas confirmed by histopathology or cytopathology;
• 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);
• The maximum diameter of pancreatic primary lesion and positive lymph node ≤7cm;
• Pancreas primary lesion or positive lymph node did not invade digestive tract (stomach, duodenum and small intestine);
• Eastern Cooperative Oncology Group (ECOG) performance score 0-1;
• Adequate bone marrow function (neutrophil count ≥1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥10.0g/dL);
• Adequate liver function (total bilirubin <1.5 times the upper limit of normal value, aminotransferase <2.5 times the upper limit of normal value);
• Adequate renal function (serum creatinine <2mg/dL, or creatinine clearance >50mL/min).

Exclusion criteria

• Multiple primary pancreatic lesions (>1);
• Tumor invaded the adjacent digestive tract;
• Radiation therapy history;
• Other local treatments history for pancreatic cancer, such as HIFU and irreversible electroporation;
• The irradiation dose of organs at risk cannot reach the dose constraint;
• Other malignant tumors history;
• Inability to understand the purpose of treatment or unwillingness/inability to sign informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Shanghai Proton and Heavy Ion Center — Shanghai

Identifiers

NCT: NCT05424159 · SPHIC-TR-PaCa2022-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗