Status:
COMPLETED
Different Patterns of Target Delineation in SBRT for Locally Advanced Pancreatic Cancer
Lead Sponsor:
Changhai Hospital
Conditions:
Treatment
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 canc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2025
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT04699539
Start Date
December 1 2020
End Date
August 16 2025
Last Update
December 10 2025
Active Locations (1)
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1
Changhai hospital
Shanghai, Shanghai Municipality, China, 200433