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

Primary Purpose

Pancreatic Cancer Non-resectable

Status

Not yet recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Carbon ion radiotherapy

About this trial

This is an interventional treatment trial for Pancreatic Cancer Non-resectable focused on measuring Locally advanced unresectable pancreatic cancer, Carbon ion radiotherapy, Phase II clinical trial, Ablative dose, Optimized linear energy transfer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Shanghai Proton and Heavy Ion Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with locally advanced unresectable pancreatic cancer

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

2-year Overall survival (OS)

OS was defined as the percentage of patients dead in the intentional population.

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).

Late toxicity

Full Information

NCT ID

NCT05424159

First Posted

June 10, 2022

Last Updated

June 22, 2022

Sponsor

Shanghai Proton and Heavy Ion Center

1. Study Identification

Unique Protocol Identification Number

NCT05424159

Brief Title

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

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

June 2022 (Anticipated)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Proton and Heavy Ion Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer Non-resectable

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Radiation: carbon ion radiotherapy for tumors without invasion of GI

Masking

None (Open Label)

Allocation

N/A

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients with locally advanced unresectable pancreatic cancer

Arm Type

Experimental

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

Carbon ion radiotherapy

Intervention Description

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 Measure Information:

Title

2-year cumulative local regional progression rate (LRP)

Description

LRP was defined as the percentage of patients with local disease progression (within irradiated area) in the intentional population.

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 Measure Information:

Title

2-year Overall survival (OS)

Description

OS was defined as the percentage of patients dead in the intentional population.

Time Frame

From the date of diagnosis until the date of death from any cause, assessed up to 24 months.

Title

Acute toxicity

Description

Time Frame

From the date of the initiation of radiotherapy until the date of 3 months after radiotherapy.

Title

Late toxicity

Description

Time Frame

3 months after radiotherapy.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zheng Wang, MD, PhD

Phone

+86-02138296666-53407

zheng.wang@sphic.org.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Wenna Zhang, MD

Phone

+86-02138296666-53404

wenna.zhang@sphic.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zheng Wang, MD, PhD

Organizational Affiliation

Shanghai Proton and Heavy Ion Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Wenna Zhang, MD

Organizational Affiliation

Shanghai Proton and Heavy Ion Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shanghai Proton and Heavy Ion Center

City

Shanghai

ZIP/Postal Code

201315

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wenna Zhang, MD

Phone

+86-02138296666

Ext

53404

wenna.zhang@sphic.org.cn

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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