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

Naval Military Medical University

Status: Completed

Conditions: Treatment

Treatments: Radiation: SBRT; Drug: Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04603586

Changhai Hospit

Details and patient eligibility

About

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.

Enrollment: 119 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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119 participants in 2 patient groups

Arm A

Active Comparator group

Description:

SBRT of BED\<70Gy combined with Gemcitabine + albumin-bound paclitaxel

Treatment:

Drug: Chemotherapy

Radiation: SBRT

Arm B

Experimental group

Description:

SBRT of BED \>70Gy combined with Gemcitabine + albumin-bound paclitaxel

Treatment:

Drug: Chemotherapy

Radiation: SBRT