Using Cyberknife to treat borderline resectable or locally advanced pancreatic cancer
Safety and Efficacy of Cyberknife in Patients With Borderline Resectable or Locally Advanced Pancreatic Adenocarcinoma: Open Label Prospective Randomized Clinical Trial
This study is testing if a special type of radiation therapy called Cyberknife can help people with tough-to-treat pancreatic cancer shrink their tumors enough to consider surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Capital Health System, Inc Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Pennington, New Jersey) |
| Trial ID | NCT04998552 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of Cyberknife stereotactic body radiation therapy (SBRT) in patients with borderline resectable or locally advanced pancreatic adenocarcinoma. Participants will receive standard neoadjuvant chemotherapy followed by either SBRT or intensity-modulated radiation therapy (IMRT) after a wash-out period. The study aims to determine if SBRT can limit or reverse tumor growth, making previously unresectable tumors eligible for surgical intervention. Patient progress will be monitored through a multidisciplinary tumor board to decide on further treatment options.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of Stage I to Stage III pancreatic adenocarcinoma who have completed neoadjuvant chemotherapy.
Not a fit: Patients with distant metastasis or those who are pregnant or lactating will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and quality of life for patients with challenging pancreatic cancer cases.
How similar studies have performed: While there have been studies on radiation therapy for pancreatic cancer, the specific use of Cyberknife in this context is relatively novel and not extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Able to sign the informed consent and understand the consenting process * Completed neoadjuvant chemotherapy regimen * Patient is 18 years of age and older * Eastern Cooperative Oncology Group (ECOG) Status of 0-1. * Patient has a diagnosis of Stage I to Stage III pancreatic cancer cytologically or pathologically confirmed per American Joint Committee on Cancer (AJCC) staging criteria and NCCN guidelines, based on radiographic imaging or exploratory laparoscopic surgery, low degree of arterial involvement (CA, CHA, SMA) and no aorta involvement. * Patients who are deemed eligible for IMRT or SBRT and approved to receive radiation therapy by multidisciplinary tumor board * Patient shows no evidence of disease progression to distant metastasis based on NCCN. * Negative pregnancy test Exclusion Criteria: * Pregnant or lactating female patients of reproductive potential who are not willing to employ highly effective birth control from screening to 6 months after the last dose of radiation therapy. * Resectable pancreatic cancer (See addendum, NCCN Guidelines 2021, PANC-2) * Unresectable pancreatic cancer (See addendum, NCCN Guidelines 2021, PANC-6) * Patients who are unable to tolerate general anesthetic with full skeletal muscle blockade. * Patients with implanted cardiac pacemakers, defibrillators, electronic devices or implanted devices with metal parts in the thoracic cavity. * Life expectancy of \< 1 year
Where this trial is running
Pennington, New Jersey
- Capital Health Medical Center-Hopewell — Pennington, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Shirnett Williamson, MD — Capital Health System, Inc
- Study coordinator: Shirnett Williamson, MD
- Email: swilliamson@capitalhealth.org
- Phone: 609-303-4244
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.