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RecruitingNCT05424159Updated Dec 7, 2023

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

An interventional study of Carbon ion radiotherapy in Pancreatic Cancer Non-resectable, sponsored by Shanghai Proton and Heavy Ion Center. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-12-07.

Sponsored by Shanghai Proton and Heavy Ion Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Pancreatic Cancer Non-resectable

Keywords

  • Locally advanced unresectable pancreatic cancer
  • Carbon ion radiotherapy
  • Phase II clinical trial
  • Ablative dose
  • Optimized linear energy transfer
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
48 participants (estimated)

Study arms

  • 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

Interventions

  • RadiationCarbon 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.

05

What researchers measure

Primary outcomes

  1. 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.

    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 outcomes

  1. 2-year Overall survival (OS)

    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.

  2. 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).

    Time frame: From the date of the initiation of radiotherapy until the date of 3 months after radiotherapy.

  3. 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).

    Time frame: 3 months after radiotherapy.

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05424159
Lead sponsor
Shanghai Proton and Heavy Ion Center
Responsible party
Guoliang Jiang (Principal Investigator, Shanghai Proton and Heavy Ion Center) — Principal investigator
First posted
Jun 21, 2022
Start date
Jul 1, 2022
Primary completion
Dec 2025 (estimated)
Completion
Dec 2026 (estimated)
Last update
Dec 7, 2023

Study contacts

Zheng Wang, MD, PhD
Contact
zheng.wang@sphic.org.cn
+86-02138296666 ext. 53407
Guo-Liang Jiang, MD
Contact
guoliang.jiang@sphic.org.cn
+86-02138296606
Zheng Wang, MD, PhD
principal investigator · Shanghai Proton and Heavy Ion Center
Xin Cai, MD
principal investigator · Shanghai Proton and Heavy Ion Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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