Clinical trial NCT05424159: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Cancer Non-resectable
Keywords: Locally advanced unresectable pancreatic cancer
Carbon ion radiotherapy
Phase II clinical trial
Ablative dose
Optimized linear energy transfer
Lead sponsor: Shanghai Proton and Heavy Ion Center
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Radiation: carbon ion radiotherapy for tumors without invasion of GI
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility criteria: 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 outcomes:
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.
Secondary outcomes:
measure: 2-year Overall survival (OS)
timeFrame: From the date of diagnosis until the date of death from any cause, assessed up to 24 months.
measure: Acute toxicity
timeFrame: From the date of the initiation of radiotherapy until the date of 3 months after radiotherapy.
measure: Late toxicity
timeFrame: 3 months after radiotherapy.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Proton and Heavy Ion Center
Study officials:
affiliation: Shanghai Proton and Heavy Ion Center
name: Zheng Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Proton and Heavy Ion Center
name: Xin Cai, MD
role: PRINCIPAL_INVESTIGATOR
References: