High Risk Localised Pancreatic Cancer Clinical Trial
— Span-COfficial 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)
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.
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | October 5, 2028 |
| Est. primary completion date | October 5, 2028 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 86 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Royal North Shore Hospital | St Leonards | New South Wales |
| Lead Sponsor | Collaborator |
|---|---|
| Royal North Shore Hospital |
Australia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | freedom of local failure | patient who do no have local failure | 12 months from end of radiotherapy | |
| Secondary | Incidence of SBRT treatment related adverse events in this group of patients | assess acute and late radiotherapy toxicity using CTCAE version 4.3, to compare toxicity with conventional treatment | Acute toxicity-from start of SBRT up to 3 months after SBRT. Late RT toxicity: from 3 months to 2 years after SBRT. | |
| Secondary | Response to neoadjuvant treatments | Determine by pathology and radiological response rates after neoadjuvant treatment, | from date of surgery through to 24 months post surgery | |
| Secondary | Feasibility of internal-external correlation model (MATT) | 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. | during SBRT radiotherapy treatment | |
| Secondary | Surgical complications | To assess surgical complications | 30 to 90 days post surgery | |
| Secondary | Duration of hospital admission after surgery | to assess extended stay in the hospital after surgery | from date of surgery through study completion (ie 24 months) | |
| Secondary | margin negative (R0) resection rate | to assess margin negative resection rate (i.e. response to treatment) | through study completion, average of 2 years | |
| Secondary | median overall survival (OS) | To assess median overall survival after treatment | 12 months after treatment | |
| Secondary | progression free survival (PFS) | To assess the PFS rate after treatment | 12 months after treatment | |
| Secondary | Feasibility of Using Kilovoltage Intra-fraction Monitoring (KIM) to determine pancreas motion | 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. | during SBRT radiotherapy treatment |