Prospective Phase II Clinical Trial of Ablative Carbon Ion Radiotherapy With Pencil Beam Scanning Using Simultaneous Integrated Boost for Locally Advanced Unresectable Pancreatic Cancer

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
China
Shanghai Proton and Heavy Ion Center
RECRUITING
Shanghai
Contact Information
Primary
Zheng Wang, MD, PhD
zheng.wang@sphic.org.cn
+86-02138296666
Backup
Guo-Liang Jiang, MD
guoliang.jiang@sphic.org.cn
+86-02138296606
Time Frame
Start Date: 2022-07-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 48
Treatments
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).
Authors
Wenna Zhang
Related Therapeutic Areas
Sponsors
Leads: Shanghai Proton and Heavy Ion Center

This content was sourced from clinicaltrials.gov