Royal North Shore Hospital
St Leonards, New South Wales, 2065, Australia
Active, Not Recruiting
NCT Number: NCT03505229
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.
Active, Not Recruiting
This study is active but is not currently recruiting participants.
Notify MeKey information
Conditions
Age range
18 year–86 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Stereotactic body radiotherapy (SBRT)
RadiationStereotactic Body Radiotherapy (SBRT) 30-45 gray in 5 fractions over 2 weeks will be given to all eligible patients.
Primary outcomes
-
freedom of local failure
Time frame: 12 months from end of radiotherapy
patient who do no have local failure
Secondary outcomes
-
Incidence of SBRT treatment related adverse events in this group of patients
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 30 to 90 days post surgery
To assess surgical complications
-
Duration of hospital admission after surgery
Time frame: from date of surgery through study completion (ie 24 months)
to assess extended stay in the hospital after surgery
-
margin negative (R0) resection rate
Time frame: through study completion, average of 2 years
to assess margin negative resection rate (i.e. response to treatment)
-
median overall survival (OS)
Time frame: 12 months after treatment
To assess median overall survival after treatment
-
progression free survival (PFS)
Time frame: 12 months after treatment
To assess the PFS rate after treatment
-
Feasibility of Using Kilovoltage Intra-fraction Monitoring (KIM) to determine pancreas motion
Time frame: 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.
Sponsors and collaborators
Lead sponsor
Royal North Shore Hospital
Other
Registry information
Official study title
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)
Acronym: Span-C
Important dates
- Study start
- 2018
- Primary completion
- 2028
- Study completion
- 2028
- First posted
- Apr 23, 2018
- Registry last updated
- Jan 29, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.