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

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer Non-resectable
• Intervention / Treatment: Radiation: Carbon ion radiotherapy

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).

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zheng Wang, MD, PhD; Phone Number: 53407 +86-02138296666; Email: zheng.wang@sphic.org.cn
• Study Contact Backup: Name: Guo-Liang Jiang, MD; Phone Number: +86-02138296606; Email: guoliang.jiang@sphic.org.cn

Study Locations

• China
  • Shanghai, China, 201315
    • Recruiting
    • Shanghai Proton and Heavy Ion Center
    • Contact: Zheng Wang, MD; Phone Number: 53407 +86-02138296666; Email: zheng.wang@sphic.org.cn
    • Contact: Guo-Liang Jiang, MD; Phone Number: 8621 38296606; Email: guoliang.jiang@sphic.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients with locally advanced unresectable pancreatic cancer; Patients with locally advanced unresectable pancreatic cancer without invasion of the gastrointestinal tract, cT4N0-2M0 Stage III (AJCC/UICC Version 8).

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-year cumulative local regional progression rate (LRP)	LRP was defined as the percentage of patients with local disease progression (within irradiated area) in the intentional population.	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

Outcome Measure	Measure Description	Time Frame
2-year Overall survival (OS)	OS was defined as the percentage of patients dead in the intentional population.	From the date of diagnosis until the date of death from any cause, assessed up to 24 months.
Acute toxicity	Toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Safety and toxicity will be assessed by clinical examination, laboratory examination, and imaging (including CT, MRI, and/or PET/CT).	From the date of the initiation of radiotherapy until the date of 3 months after radiotherapy.
Late toxicity	Toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Safety and toxicity will be assessed by clinical examination, laboratory examination, and imaging (including CT, MRI, and/or PET/CT).	3 months after radiotherapy.

Collaborators and Investigators

• Sponsor: Shanghai Proton and Heavy Ion Center
• Investigators: Principal Investigator: Zheng Wang, MD, PhD, Shanghai Proton and Heavy Ion Center; Principal Investigator: Xin Cai, MD, Shanghai Proton and Heavy Ion Center

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 10, 2022
• First Submitted That Met QC Criteria: June 15, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Phase II clinical trial; Locally advanced unresectable pancreatic cancer; Carbon ion radiotherapy; Ablative dose; Optimized linear energy transfer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: SPHIC-TR-PaCa2022-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No