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

NCT ID: NCT04603586

Last Updated: 2025-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-10
• Study Completion Date: 2025-08-15

Brief Summary

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.

Conditions

Treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

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

Group Type: ACTIVE_COMPARATOR

SBRT

Intervention Type: RADIATION

SBRT: in 5-6 fractions with CyberKnife

Chemotherapy

Intervention Type: 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

Arm B

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

Group Type: EXPERIMENTAL

SBRT

Intervention Type: RADIATION

SBRT: in 5-6 fractions with CyberKnife

Chemotherapy

Intervention Type: 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

Interventions

SBRT

SBRT: in 5-6 fractions with CyberKnife

Intervention Type: RADIATION

Chemotherapy

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changhai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhang Huo Jun

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Changhai hospital

Shanghai, Shanghai Municipality, China

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, China

Countries

China

References

Ye Y, Zhu X, Zhao X, Jiang L, Cao Y, Zhang H. Biologically effective doses of 60-70Gy versus >70Gy of stereotactic body radiotherapy (SBRT) combined with chemotherapy in locally advanced pancreatic cancer: protocol of a single-centre, phase II clinical trial. BMJ Open. 2022 Aug 29;12(8):e049382. doi: 10.1136/bmjopen-2021-049382.

Reference Type: DERIVED

PMID: 36038164 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Changhai Hospit

Identifier Type: -

Identifier Source: org_study_id