NCT04699539Completed
Different Patterns of Target Delineation in SBRT for Locally Advanced Pancreatic Cancer
Recurrence-pattern-based Volume Versus Conventional-volume Stereotactic Body Radiation Therapy in Locally Advanced Pancreatic Cancer: an Open-label, Randomized, Phase 2 Trial
Source: ClinicalTrials.gov · Last updated 10 Dec 2025
Brief summary (registry, in English)
The purpose of this study is to compare the efficacy and safety of a recurrence-pattern-based-volume versus conventional-volume stereotactic body radiation therapy for locally advanced pancreatic cancer, so as to determine whether the target delineation method based on recurrence pattern can obtain better survival benefits.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 96 (actual)
- First submitted
- 9 Nov 2020
- Start date
- 1 Dec 2020
- Primary completion date
- 16 Aug 2025
- Lead sponsor
- Changhai Hospital
- Diseases
- Pancreatic cancer
- NCT number
- NCT04699539
What you commit to
- Study type: Interventional
- Participants enrolled: 96
- From 1 Dec 2020 to the primary completion date, 16 Aug 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
- Previously receiving radiotherapy, chemotherapy, immunotherapy or targeted therapy
Other illness
- Evidences of metastatic disease confirmed by chest CT or PET-CT
- Secondary malignancy
- Patients with active inflammatory bowel diseases or peptic ulcer
- Gastrointestinal bleeding or perforation within 6 months
- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
- Medical history of symptomatic congestive heart failure: New York Heart Association Class III to IV
- Medical history of respiratory insufficiency
Age
- Age \<18 years
Other
- ECOG ≥2
- Abnormal results of blood routine examinations and liver and kidney and coagulation tests
- Women who are pregnant or breastfeeding
- Participation in another clinical treatment trial
- Inability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document
Who the study is looking for
- Cytologically or histologically verified pancreatic adenocarcinoma
- Imaging examinations confirmed locally advanced pancreatic cancer
- No previous radiotherapy, chemotherapy, immunotherapy or targeted therapy
- ECOG of 0 to1
- Age of 18 years or older
- Adequate bone marrow function, defined as: Absolute neutrophil count (ANC) ≥ 1.5×10\^9 cells/L, leukocyte count≥ 3.5×10\^9 cells/L, platelets ≥ 70×10\^9 cells/L, hemoglobin ≥ 8.0 g/dl
- Adequate liver and renal, defined as: Albumin \> 2.5 g/dL, total bilirubin \< 3 mg/dL, creatinine \< 2.0 mg/dL, AST\<2.5 × ULN (Upper Limit of Normal) (0-64U/L), ALT\<2.5 × ULN (0-64U/L)
- Adequate blood clotting function, defined as: international normalized ratio (INR) \< 2 (0.9-1.1)
- Ability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document
Age in the registry: 18 years to - · 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 |
|---|---|---|---|
| Changhai Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.