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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 details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2018-12-18
Primary completion: 2028-10-05
Study completion finish: 2028-10-05
Study type
TREATMENT
Phase
NA
Trial ID
NCT03505229
Intervention or treatment
RADIATION: Stereotactic Body Radiotherapy (SBRT)
Conditions
- • High Risk Localised Pancreatic Cancer
Find a site
Closest Location:
Royal North Shore Hospital
Research sites nearby
Select from list below to view details:
Royal North Shore Hospital
St Leonards, New South Wales, Australia
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?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Stereotactic Body Radiotherapy (SBRT)
| RADIATION: Stereotactic Body Radiotherapy (SBRT)
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| freedom of local failure | patient who do no have local failure | 12 months from end of radiotherapy |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome 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. |
| 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 |
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