Stereotactic Body Radiotherapy [SBRT] for High Risk Localised Pancreatic Cancer: a Phase II Study of the Department of Radiation Oncology Royal North Shore Hospital (Span-C - SBRT for Pancreatic Cancer)
Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 86
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Australia
Royal North Shore Hospital
RECRUITING
St Leonards
Contact Information
Primary
Carol Kwong
carolyn.kwong@health.nsw.gov.au
+61 2 9463 1339
Backup
Heidi Tsang
heidi.tsang@health.nsw.gov.au
+61 2 9463 1340
Time Frame
Start Date: 2018-12-18
Estimated Completion Date: 2028-10-05
Participants
Target number of participants: 40
Treatments
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 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.
Related Therapeutic Areas
Sponsors
Leads: Royal North Shore Hospital