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

S

Shanghai Proton and Heavy Ion Center

Status

Enrolling

Conditions

Pancreatic Cancer Non-resectable

Treatments

Radiation: Carbon ion radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05424159
SPHIC-TR-PaCa2022-01

Details and patient eligibility

About

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.

Full 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).

Enrollment

48 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

48 participants in 1 patient group

Patients with locally advanced unresectable pancreatic cancer
Experimental group
Description:
Patients with locally advanced unresectable pancreatic cancer without invasion of the gastrointestinal tract, cT4N0-2M0 Stage III (AJCC/UICC Version 8).
Treatment:
Radiation: Carbon ion radiotherapy

Trial contacts and locations

1

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Central trial contact

Guo-Liang Jiang, MD; Zheng Wang, MD, PhD

Data sourced from clinicaltrials.gov

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