NCT05424159Recruiting
Ablative Carbon Ion Radiotherapy With Pencil Beam Scanning for Locally Advanced Unresectable Pancreatic Cancer
Prospective Phase II Clinical Trial of Ablative Carbon Ion Radiotherapy With Pencil Beam Scanning Using Simultaneous Integrated Boost for Locally Advanced Unresectable Pancreatic Cancer
Source: ClinicalTrials.gov · Last updated 7 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 10 Jun 2022
- Start date
- Jul 2022
- Primary completion date
- Dec 2025
- Lead sponsor
- Shanghai Proton and Heavy Ion Center
- Diseases
- Pancreatic cancer
- NCT number
- NCT05424159
What you commit to
- Study type: Interventional
- Planned participants: 48
- From Jul 2022 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Radiation therapy history;
- The irradiation dose of organs at risk cannot reach the dose constraint;
Other illness
- Other local treatments history for pancreatic cancer, such as HIFU and irreversible electroporation;
- Other malignant tumors history;
Other
- Multiple primary pancreatic lesions (\>1);
- Tumor invaded the adjacent digestive tract;
- Inability to understand the purpose of treatment or unwillingness/inability to sign informed consent.
Who the study is looking for
- 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).
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Proton and Heavy Ion Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.