NCT03505229

Span-C-SBRT for Pancreatic Cancer

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: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Royal North Shore Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 86 Years
• Healthy volunteers: Not accepted

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.

Conditions

• High Risk Localised Pancreatic Cancer

Interventions

Type	Name	Description
RADIATION	Stereotactic Body Radiotherapy (SBRT)	Stereotactic Body Radiotherapy (SBRT) 30-45 gray in 5 fractions over 2 weeks will be given to all eligible patients.

Timeline

• Start date: 2018-12-18
• Primary completion: 2028-10-05
• Completion: 2028-10-05
• First posted: 2018-04-23
• Last updated: 2026-01-29

Locations

1 site across 1 country: Australia