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2018-12-18
2028-10-05
2028-10-05
40
NCT03505229
Royal North Shore Hospital
Royal North Shore Hospital
INTERVENTIONAL
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-03-05 | N/A | 2023-11-14 |
2018-04-16 | N/A | 2023-11-18 |
2018-04-23 | N/A | 2023-11 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: 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 treatme | RADIATION: Stereotactic Body Radiotherapy (SBRT)
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| freedom of local failure | patient who do no have local failure | 12 months from end of radiotherapy |
| Secondary Outcome Measures | 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. |
| 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Carol Kwong Phone Number: +61 2 9463 1339 Email: carolyn.kwong@health.nsw.gov.au |
Study Contact Backup Name: Heidi Tsang Phone Number: +61 2 9463 1340 Email: heidi.tsang@health.nsw.gov.au |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
