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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Stereotactic Body Radiotherapy (SBRT) 30-45 gray in 5 fractions over 2 weeks will be given to all eligible patients.
Royal North Shore Hospital
St Leonards, New South Wales, Australia
freedom of local failure
patient who do no have local failure
Time frame: 12 months from end of radiotherapy
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
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
Determine by pathology and radiological response rates after neoadjuvant treatment,
Time frame: 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.
Time frame: during SBRT radiotherapy treatment
Surgical complications
To assess surgical complications
Time frame: 30 to 90 days post surgery
Duration of hospital admission after surgery
to assess extended stay in the hospital after surgery
Time frame: 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)
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Time frame: through study completion, average of 2 years
median overall survival (OS)
To assess median overall survival after treatment
Time frame: 12 months after treatment
progression free survival (PFS)
To assess the PFS rate after treatment
Time frame: 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.
Time frame: during SBRT radiotherapy treatment