Mode
Text Size
Log in / Sign up
N/A N=119 Randomized Treatment

Stereotactic Radiotherapy in Locally Advanced Pancreatic Cancer With Different Biological Effective Doses

Treatment

Enrolled (actual)
119
Serious AEs
42.9%
Results posted
Oct 2025
Primary outcome: Primary: Progression-Free-Survival — 8.6; 11.3 month

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
SBRT (Radiation); Chemotherapy (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Changhai Hospital
Primary completion
Aug 2025

Outcome Measures

OutcomeResultp-value
PRIMARY
Progression-Free-Survival
8.6; 11.3
SECONDARY
Adverse Events
58; 57
SECONDARY
Overall Survival
12.2; 17.2

Summary

The aim of this study is to compare the safety and efficacy of SBRT in LAPC with different biological effective dose (BED) ( 70Gy ) , to identify a dose range that could achieve better survival benefit and minimize the toxicity of radiotherapy.

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, 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04603586). 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.

Back to search