High Risk Localised Pancreatic CancerSpan-CNCT03505229
Span-C-SBRT for Pancreatic Cancer
A study testing Stereotactic Body Radiotherapy (SBRT) in people with High Risk Localised Pancreatic Cancer, run by Royal North Shore Hospital at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 86 years
- Conditions the study is for
- High Risk Localised Pancreatic Cancer
- What is being tested?
- Stereotactic Body Radiotherapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- 18 Dec 2018to 5 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Royal North Shore Hospital
St Leonards, New South Wales, 2065
About this study
Official title: 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.
Read the 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.
- Conditions
- High Risk Localised Pancreatic Cancer
- Being tested
- Stereotactic Body Radiotherapy (SBRT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Stereotactic Body Radiotherapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
freedom of local failure
patient who do no have local failure
Measured: 12 months from end of radiotherapy
Secondary outcomes (9)
Incidence of SBRT treatment related adverse events in this group of patients
assess acute and late radiotherapy toxicity using CTCAE version 4.3, to compare toxicity with conventional treatment
Measured: 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
Determine by pathology and radiological response rates after neoadjuvant treatment,
Measured: from date of surgery through to 24 months post surgery
Feasibility of internal-external correlation model (MATT)
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.
Measured: during SBRT radiotherapy treatment
Surgical complications
To assess surgical complications
Measured: 30 to 90 days post surgery
Duration of hospital admission after surgery
to assess extended stay in the hospital after surgery
Measured: from date of surgery through study completion (ie 24 months)
margin negative (R0) resection rate
to assess margin negative resection rate (i.e. response to treatment)
Measured: through study completion, average of 2 years
median overall survival (OS)
To assess median overall survival after treatment
Measured: 12 months after treatment
progression free survival (PFS)
To assess the PFS rate after treatment
Measured: 12 months after treatment
Feasibility of Using Kilovoltage Intra-fraction Monitoring (KIM) to determine pancreas motion
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.
Measured: during SBRT radiotherapy treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start18 Dec 2018
- Primary completion5 Oct 2028 (estimated)
- Study completion5 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for High Risk Localised Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- non randomised-single arm phase II
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal North Shore Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- George Hruby, FRANZCR, Principal investigator, Northern Sydney Local Health District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505229
- Sponsor's protocol ID
- Span-C
- Acronym
- Span-C
- Status last verified
- Jan 2026
- First submitted
- 5 Mar 2018
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: aim to present study data in conferences and medical journals
Publications
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.
PubMed 40521621Madden 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.
PubMed 38588646
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03505229
- Acronym / sponsor ID
- Span-C / Span-C
- Conditions
- High Risk Localised Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Royal North Shore HospitalUniversity, hospital or other
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 5 Oct 2028 (estimated)
- Study completion
- 5 Oct 2028 (estimated)
- First posted
- 23 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- non randomised-single arm phase II
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Body Radiotherapy (SBRT) | Experimental | Radiation: 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. |
Who may qualify
- Ages
- 18 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- Patients with metastatic pancreas cancer
- Prior abdominal radiotherapy
- Active malignancy excluding non melanomatous skin cancer
- Neuroendocrine pancreatic carcinoma
- Pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Body Radiotherapy (SBRT)Stereotactic Body Radiotherapy (SBRT) 30-45 gray in 5 fractions over 2 weeks will be given to all eligible patients. | Radiation | Stereotactic Body Radiotherapy (SBRT) |
Primary outcome
freedom of local failure
Time frame: 12 months from end of radiotherapy
patient who do no have local failure
9 secondary outcomes
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.
Response to neoadjuvant treatments
Time frame: from date of surgery through to 24 months post surgery
Feasibility of internal-external correlation model (MATT)
Time frame: during SBRT radiotherapy treatment
Surgical complications
Time frame: 30 to 90 days post surgery
Duration of hospital admission after surgery
Time frame: from date of surgery through study completion (ie 24 months)
margin negative (R0) resection rate
Time frame: through study completion, average of 2 years
median overall survival (OS)
Time frame: 12 months after treatment
progression free survival (PFS)
Time frame: 12 months after treatment
Feasibility of Using Kilovoltage Intra-fraction Monitoring (KIM) to determine pancreas motion
Time frame: during SBRT radiotherapy treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Derived from this study: PubMed 40521621Chan 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.
- Derived from this study: PubMed 38588646Madden 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.
- Individual participant dataSharing planned: Yes. aim to present study data in conferences and medical journals
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Hruby, FRANZCR principal investigator
Northern Sydney Local Health District
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Body Radiotherapy (SBRT) in people with High Risk Localised Pancreatic Cancer, run by Royal North Shore Hospital at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
freedom of local failure (time frame: 12 months from end of radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03505229, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.