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OpenTrials
Completed

NCT Number: NCT04699539

Different Patterns of Target Delineation in SBRT for Locally Advanced Pancreatic Cancer

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.

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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, 200433, China

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, 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

Treatment and study plan

SBRT

Radiation

A conventional-volume stereotactic body radiation therapy: planning target volume should include gross tumor volume with a uniform 3mm margin in all directions.

A recurrence-pattern-based volume stereotactic body radiation therapy: planning target volume should include gross tumor volume with a 3mm margin in the anterior and lateral directions, 10mm margin in the cranial and caudal directions that should cover the full circumstance of celiac artery and superior mesenteric artery, 15mm in the posterior direction that should cover the retroperitoneal space.

The prescribed dose of PTV varies from 30-50Gy/5-6f.

Chemotherapy

Drug

Gemcitabine (1000mg/m2,d1, 8) + albumin-bound paclitaxel (125mg/m2,d1, 8) , repeat every 3 weeks for 6 cycles

Primary outcomes

  1. 1-year Progression Free Survival Rate

    Time frame: 1 year

    The proportion of patients without disease progression at one year

Secondary outcomes

  1. Treatment-related Adverse Events

    Time frame: 4 years

    Treatment-related adverse events

  2. Progression Free Survival

    Time frame: 4 years

    Progression free survival

  3. Overall Survival

    Time frame: 4 years

    Overall Survival

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

Recurrence-pattern-based Volume Versus Conventional-volume Stereotactic Body Radiation Therapy in Locally Advanced Pancreatic Cancer: an Open-label, Randomized, Phase 2 Trial

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jan 7, 2021
Registry last updated
Dec 10, 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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