High Risk Localised Pancreatic Cancer
Conditions
Brief 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.
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.
Interventions
RADIATIONStereotactic Body Radiotherapy (SBRT)
Stereotactic Body Radiotherapy (SBRT) 30-45 gray in 5 fractions over 2 weeks will be given to all eligible patients.
Sponsors
Royal North Shore Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
no masking
Intervention model description
non randomised-single arm phase II
Eligibility
Sex/Gender
ALL
Age
18 Years to 86 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| freedom of local failure | 12 months from end of radiotherapy | patient who do no have local failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of SBRT treatment related adverse events in this group of patients | 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 |
| Response to neoadjuvant treatments | from date of surgery through to 24 months post surgery | Determine by pathology and radiological response rates after neoadjuvant treatment, |
| Feasibility of internal-external correlation model (MATT) | 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. |
| Surgical complications | 30 to 90 days post surgery | To assess surgical complications |
| Duration of hospital admission after surgery | from date of surgery through study completion (ie 24 months) | to assess extended stay in the hospital after surgery |
| margin negative (R0) resection rate | through study completion, average of 2 years | to assess margin negative resection rate (i.e. response to treatment) |
| median overall survival (OS) | 12 months after treatment | To assess median overall survival after treatment |
| progression free survival (PFS) | 12 months after treatment | To assess the PFS rate after treatment |
| Feasibility of Using Kilovoltage Intra-fraction Monitoring (KIM) to determine pancreas motion | 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. |
Countries
Australia
Contacts
PRINCIPAL_INVESTIGATORGeorge Hruby, FRANZCR
Northern Sydney Local Health District
Outcome results
None listed