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

NCT ID: NCT05424159

Last Updated: 2023-12-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2026-12-31

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).

Conditions

Pancreatic Cancer Non-resectable

Keywords

Locally advanced unresectable pancreatic cancer; Carbon ion radiotherapy; Phase II clinical trial; Ablative dose; Optimized linear energy transfer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Carbon ion radiotherapy

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Proton and Heavy Ion Center

OTHER

Sponsor Role: lead

Responsible Party

Guoliang Jiang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zheng Wang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Proton and Heavy Ion Center

Xin Cai, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Proton and Heavy Ion Center

Locations

Shanghai Proton and Heavy Ion Center

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Zheng Wang, MD, PhD

Role: CONTACT

Phone: +86-02138296666

Email: zheng.wang@sphic.org.cn

Guo-Liang Jiang, MD

Role: CONTACT

Phone: +86-02138296606

Email: guoliang.jiang@sphic.org.cn

Facility Contacts

Zheng Wang, MD

Role: primary

Guo-Liang Jiang, MD

Role: backup

Other Identifiers

SPHIC-TR-PaCa2022-01

Identifier Type: -

Identifier Source: org_study_id