N/A
Completed N=96
Different Patterns of Target Delineation in SBRT for Locally Advanced Pancreatic Cancer
Treatment
Source: ClinicalTrials.gov NCT04699539 ↗
Enrolled (actual)
96
Serious AEs
42.7%
Results posted
Dec 2025
Primary outcomePrimary: 1-year Progression Free Survival Rate — 9; 18 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 1-year Progression Free Survival Rate |
9; 18 | — |
| SECONDARY Treatment-related Adverse Events |
45; 46 | — |
| SECONDARY Progression Free Survival |
7.3; 9.6 | — |
| SECONDARY Overall Survival |
10.8; 15.2 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Previously receiving radiotherapy, chemotherapy, immunotherapy or targeted therapy
- Evidences of metastatic disease confirmed by chest CT or PET-CT
- ECOG ≥2
- Age <18 years
- Secondary malignancy
- Abnormal results of blood routine examinations and liver and kidney and coagulation tests
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT04699539). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.