Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| freedom of local failure | patient who do no have local failure | 12 months from end of radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Acute toxicity-from start of SBRT up to 3 months after SBRT. Late RT toxicity: from 3 months to 2 years after SBRT. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| George Hruby, FRANZCR | Northern Sydney Local Health District | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal North Shore Hospital | St Leonards | New South Wales | 2065 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40521621 | Derived | 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. | |
| 38588646 |
Not provided
Not provided
aim to present study data in conferences and medical journals
end of trial after analysis
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
Not provided
Not provided
non randomised-single arm phase II
Not provided
Not provided
no masking
Not provided
| Response to neoadjuvant treatments |
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) | 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 | To assess surgical complications | 30 to 90 days post surgery |
| Duration of hospital admission after surgery | to assess extended stay in the hospital after surgery | 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) | through study completion, average of 2 years |
| median overall survival (OS) | To assess median overall survival after treatment | 12 months after treatment |
| progression free survival (PFS) | To assess the PFS rate after treatment | 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. | during SBRT radiotherapy treatment |
| 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. |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |