Health TrialsbyHealthPanel

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

ConditionPancreatic Cancer Non-resectable
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Proton and Heavy Ion Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Carbon ion radiotherapy

    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.

Treatment groups

48 Participants
are divided into 1 treatment group
Group A: Patients with locally advanced unresectable pancreatic cancerExperimental treatment 1 intervention

Trial outcomes

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Proton and Heavy Ion Center

Lead sponsor

Source ClinicalTrials.gov
Apply now