Clinical trial NCT03505229: Span-C-SBRT for Pancreatic Cancer
Official 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: High Risk Localised Pancreatic Cancer
Lead sponsor: Royal North Shore Hospital
Sponsor class: OTHER
First posted: 2018-04-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: non randomised-single arm phase II
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: freedom of local failure
timeFrame: 12 months from end of radiotherapy
Secondary outcomes:
measure: Incidence of SBRT treatment related adverse events in this group of patients
timeFrame: Acute toxicity-from start of SBRT up to 3 months after SBRT. Late RT toxicity: from 3 months to 2 years after SBRT.
measure: Response to neoadjuvant treatments
timeFrame: from date of surgery through to 24 months post surgery
measure: Feasibility of internal-external correlation model (MATT)
timeFrame: during SBRT radiotherapy treatment
measure: Surgical complications
timeFrame: 30 to 90 days post surgery
measure: Duration of hospital admission after surgery
timeFrame: from date of surgery through study completion (ie 24 months)
measure: margin negative (R0) resection rate
timeFrame: through study completion, average of 2 years
measure: median overall survival (OS)
timeFrame: 12 months after treatment
measure: progression free survival (PFS)
timeFrame: 12 months after treatment
measure: Feasibility of Using Kilovoltage Intra-fraction Monitoring (KIM) to determine pancreas motion
timeFrame: during SBRT radiotherapy treatment
Other outcomes:
Locations:
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
Study officials:
affiliation: Northern Sydney Local Health District
name: George Hruby, FRANZCR
role: PRINCIPAL_INVESTIGATOR
References: