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

NCT04603586 | Completed Results

• 1 other identifier: Changhai Hospit
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 2

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

Keywords

SBRT; Locally Advanced Pancreatic Cancer; Biological Effective Dose

Outcome Measures

Primary Outcomes (1)

• Progression-Free-Survival

  Progression-Free-Survival

  3 years

Secondary Outcomes (2)

• Adverse Events

  3 years

• Overall Survival

  3 years

Study Arms (2)

Arm A

ACTIVE COMPARATOR

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

Radiation: SBRT; Drug: Chemotherapy

Arm B

EXPERIMENTAL

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

Radiation: SBRT; Drug: Chemotherapy

Interventions

SBRT RADIATION

SBRT: in 5-6 fractions with CyberKnife

Arm A; Arm B

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

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (2)

Changhai hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (1)

• 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.

  PMID: 36038164 DERIVED

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Xiaofei Zhu
• Organization: Changhai Hospital

zhuxiaofei_zxf@163.com

86-021-31162222

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 27, 2020
• Study Start: November 10, 2020
• Primary Completion: August 15, 2025
• Study Completion: August 15, 2025
• Last Updated: October 20, 2025
• Results First Posted: October 20, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)