NCT03505229

Brief Summary

To assess the freedom from local failure at 12 months after Stereotactic Body Radiotherapy (SBRT). Also to assess the safety, efficacy and feasibility of SBRT in the treatment of high risk localised pancreatic cancer.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
29mo left

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Dec 2018Oct 2028

First Submitted

Initial submission to the registry

March 5, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 23, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

December 18, 2018

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2028

Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

9.8 years

First QC Date

March 5, 2018

Last Update Submit

January 27, 2026

Conditions

High Risk Localised Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • freedom of local failure

    patient who do no have local failure

    12 months from end of radiotherapy

Secondary Outcomes (9)

  • Incidence of SBRT treatment related adverse events in this group of patients

    Acute toxicity-from start of SBRT up to 3 months after SBRT. Late RT toxicity: from 3 months to 2 years after SBRT.

  • Response to neoadjuvant treatments

    from date of surgery through to 24 months post surgery

  • Feasibility of internal-external correlation model (MATT)

    during SBRT radiotherapy treatment

  • Surgical complications

    30 to 90 days post surgery

  • Duration of hospital admission after surgery

    from date of surgery through study completion (ie 24 months)

  • +4 more secondary outcomes

Study Arms (1)

Stereotactic Body Radiotherapy (SBRT)

EXPERIMENTAL

Prior to SBRT, fiducial markers will be placed to aid with image guidance during radiation delivery. Fiducials will be inserted endoscopically (preferable) or intraoperatively. After this procedure, patients will have radiotherapy planning. During treatment, the fiducials will be used for registration with the images acquired during treatment (including kV fluoroscopy, MV or optical). The acquired images may be processed to determine fiducial location using KIM or MATT software from University of Sydney. SBRT 30-45Gray in 5 fractions will be given over 2 weeks. Four weeks after completion of SBRT participants will repeat a re-staging PET and CT scans. Those considered to be resectable will proceed to have surgery 6-10 weeks post SBRT.

Radiation: Stereotactic Body Radiotherapy (SBRT)

Interventions

Stereotactic Body Radiotherapy (SBRT)RADIATION

Stereotactic Body Radiotherapy (SBRT) 30-45 gray in 5 fractions over 2 weeks will be given to all eligible patients.

Stereotactic Body Radiotherapy (SBRT)

Eligibility Criteria

Age18 Years - 86 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 and able to give informed consent
  • Patients with histologically or cytologically confirmed locally advanced adenocarcinoma of the pancreas, including patients with extrapancreatic extension (Stage IIA), node positive (Stage IIB), borderline resectable or locally advanced as defined by AGITG guidelines
  • ECOG performance status 0-1
  • Measurable disease as defined by RECIST 1.1
  • Have received or plan to receive chemotherapy
  • Successful insertion of fiducial markers

You may not qualify if:

  • Patients with metastatic pancreas cancer
  • Prior abdominal radiotherapy
  • Active malignancy excluding non melanomatous skin cancer
  • Neuroendocrine pancreatic carcinoma
  • Pregnant or lactating women
  • Tumour size greater then 70mm
  • Age \>85

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Related Publications (2)

  • Chan J, Kneebone A, Metz G, Booth J, Shepherd M, Kwong C, Brown C, Norton I, Clarke S, Diakos C, Pavlakis N, Mittal A, Samra J, Hruby G. SPAN-C: Results of a Phase II Clinical Trial of Stereotactic Body Radiotherapy in Pancreatic Ductal Adenocarcinoma. J Med Imaging Radiat Oncol. 2025 Aug;69(5):593-600. doi: 10.1111/1754-9485.13874. Epub 2025 Jun 16.

    PMID: 40521621DERIVED

  • Madden L, Ahmed A, Stewart M, Chrystall D, Mylonas A, Brown R, Nguyen DT, Keall P, Booth J. CBCT-DRRs superior to CT-DRRs for target-tracking applications for pancreatic SBRT. Biomed Phys Eng Express. 2024 Apr 26;10(3). doi: 10.1088/2057-1976/ad3bb9.

    PMID: 38588646DERIVED

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • George Hruby, FRANZCR

    Northern Sydney Local Health District

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
no masking
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: non randomised-single arm phase II
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2018

First Posted

April 23, 2018

Study Start

December 18, 2018

Primary Completion (Estimated)

October 5, 2028

Study Completion (Estimated)

October 5, 2028

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

aim to present study data in conferences and medical journals

Shared Documents
CSR
Time Frame
end of trial after analysis

Locations

AU(1)