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Active (not recruiting) Not applicable NCT03505229

Span-C-SBRT for Pancreatic Cancer

No applicable phase (e.g. observational)
Conditions: High Risk Localised Pancreatic Cancer

Sponsor: Royal North Shore Hospital

trial.available_in: БГ
Overview
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.
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.
Who can participate
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
Locations 1
Australia (1)
Royal North Shore Hospital
St Leonards , New South Wales
Technical details
Status
Active (not recruiting)
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
86 Years
Healthy volunteers
No
Start date
18.12.2018
Completion date
05.10.2028
Registry ID
NCT03505229
Source
anzctr
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