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OpenTrials
Completed

NCT Number: NCT04603586

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

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changhai hospital, Shanghai, Shanghai Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SBRT

Radiation

SBRT: in 5-6 fractions with CyberKnife

Chemotherapy

Drug

Gemcitabine 1000mg/m^2 and nab-paclitaxel 125mg/m^2, administered intravenously, on day 1 and 8 of a 21-day cycle for six cycles

Primary outcomes

  1. Progression-Free-Survival

    Time frame: 3 years

    Progression-Free-Survival

Secondary outcomes

  1. Adverse Events

    Time frame: 3 years

    Adverse events

  2. Overall Survival

    Time frame: 3 years

    Overall Survival

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

A Prospective Phase Ⅱ Clinical Study of Stereotactic Radiotherapy Combined With Chemotherapy With Different Biological Effective Doses (<70gy vs. >70Gy) in Locally Advanced Pancreatic Cancer

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Oct 27, 2020
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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