Stereotactic Body Radiotherapy for High Risk Localized 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)
This study is testing if a precise type of radiation treatment, combined with chemotherapy, can help people with high-risk localized pancreatic cancer live longer without their cancer coming back.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 86 Years |
| Sex | All |
| Sponsor | Royal North Shore Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (St Leonards, New South Wales) |
| Trial ID | NCT03505229 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Stereotactic Body Radiotherapy (SBRT) in treating high risk localized pancreatic cancer. Patients with confirmed adenocarcinoma of the pancreas will undergo neoadjuvant chemotherapy followed by SBRT, which involves delivering high doses of radiation in a precise manner. The study will assess the freedom from local failure at 12 months, as well as the safety and feasibility of this treatment approach. Participants will be monitored through imaging studies to determine the potential for surgical resection after treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with high risk localized pancreatic adenocarcinoma who have a good performance status and are suitable for chemotherapy and radiotherapy.
Not a fit: Patients with metastatic pancreatic cancer or those with prior abdominal radiotherapy are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve local control of pancreatic cancer and increase the chances of surgical resection.
How similar studies have performed: Other studies have shown promising results with SBRT for pancreatic cancer, indicating that this approach is gaining traction in clinical practice.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
St Leonards, New South Wales
- Royal North Shore Hospital — St Leonards, New South Wales, Australia (Recruiting)
Study contacts
- Principal investigator: George Hruby, FRANZCR — Northern Sydney Local Health District
- Study coordinator: Carol Kwong
- Email: carolyn.kwong@health.nsw.gov.au
- Phone: +61 2 9463 1339
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.