Span-C-SBRT for Pancreatic Cancer (Span-C)

January 27, 2026 updated by: Royal North Shore Hospital

Stereotactic Body Radiotherapy [SBRT] for High Risk Localised Pancreatic Cancer: a Phase II Study of the Department of Radiation Oncology Royal North Shore Hospital (Span-C - SBRT for Pancreatic Cancer)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients must have histologically or cytologically confirmed high risk localised adenocarcinoma of the pancreas, including patients with extrapancreatic extension (Stage IIA), node positive (Stage IIB), borderline resectable or locally advanced pancreatic cancer as defined by Australasian Gastro-Intestinal Trials Group (AGITG) guidelines. ECOG performance status 0-1, suitable for chemotherapy and radiotherapy.

After a minimum of 2 months of neoadjuvant chemotherapy using either an oxaliplatin- based regimen (FOLFOX, FOLFIRINOX, mFOLFIRINOX)+/- immunotherapy/molecular agent or gemcitabine based chemotherapy (eg gemcitabine / gemcitabine/abraxane). Participants will receive SBRT (30-45Gray in 5 fractions over 2 weeks. Prior to SBRT, fiducial markers will be placed to aid with image guidance during radiation delivery. Four weeks after completion of SBRT participants will have re-staging using positron emission tomography (PET) and computed tomography (CT) scan. Participants will be discussed in the multidisciplinary team meeting for consideration of surgery. Those considered to be resectable will proceed to have surgery 6-10 weeks post SBRT.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • St Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stereotactic Body Radiotherapy (SBRT)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
freedom of local failure
Time Frame: 12 months from end of radiotherapy
patient who do no have local failure
12 months from end of radiotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of SBRT treatment related adverse events in this group of patients
Time Frame: Acute toxicity-from start of SBRT up to 3 months after SBRT. Late RT toxicity: from 3 months to 2 years after SBRT.
assess acute and late radiotherapy toxicity using CTCAE version 4.3, to compare toxicity with conventional treatment
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
Time Frame: from date of surgery through to 24 months post surgery
Determine by pathology and radiological response rates after neoadjuvant treatment,
from date of surgery through to 24 months post surgery
Feasibility of internal-external correlation model (MATT)
Time Frame: during SBRT radiotherapy treatment
Determine the feasibility of the University of Sydney internal-external correlation model (MATT) to determine pancreas motion. Feasibility is determined as predicted motion with MATT is within 2mm of actual motion measured with fluoroscopic x-rays of fiducial markers during treatment.
during SBRT radiotherapy treatment
Surgical complications
Time Frame: 30 to 90 days post surgery
To assess surgical complications
30 to 90 days post surgery
Duration of hospital admission after surgery
Time Frame: from date of surgery through study completion (ie 24 months)
to assess extended stay in the hospital after surgery
from date of surgery through study completion (ie 24 months)
margin negative (R0) resection rate
Time Frame: through study completion, average of 2 years
to assess margin negative resection rate (i.e. response to treatment)
through study completion, average of 2 years
median overall survival (OS)
Time Frame: 12 months after treatment
To assess median overall survival after treatment
12 months after treatment
progression free survival (PFS)
Time Frame: 12 months after treatment
To assess the PFS rate after treatment
12 months after treatment
Feasibility of Using Kilovoltage Intra-fraction Monitoring (KIM) to determine pancreas motion
Time Frame: during SBRT radiotherapy treatment
Determine the feasibility of the University of Sydney Kilovoltage Intra-fraction Monitoring (KIM) software to determine pancreas motion. Feasibility is determined as predicted motion with KIM is within 2mm of actual motion measured with fluoroscopic x-rays of fiducial markers during treatment.
during SBRT radiotherapy treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal North Shore Hospital

Investigators

  • Principal Investigator: George Hruby, FRANZCR, Northern Sydney Local Health District

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2018

Primary Completion (Estimated)

October 5, 2028

Study Completion (Estimated)

October 5, 2028

Study Registration Dates

First Submitted

March 5, 2018

First Submitted That Met QC Criteria

April 16, 2018

First Posted (Actual)

April 23, 2018

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Span-C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

aim to present study data in conferences and medical journals

IPD Sharing Time Frame

end of trial after analysis

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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