Using Cyberknife to treat borderline resectable or locally advanced pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.