Safety and Efficacy of Cyberknife in Patients With Borderline Resectable or Locally Advanced Pancreatic Adenocarcinoma: Open Label Prospective Randomized Clinical Trial

Trial ID: NCT04998552

Interventional - Phase Unknown - Recruiting

The hypothesize that SBRT will limit or reverse tumor growth and thereby convert the borderline resectable disease or locally advanced disease in to a resectable tumor. Furthermore, we want to assess whether SBRT leads to an improved quality of life compared to IMRT.

Conditions

• Pancreas Adenocarcinoma

Interventions

• Cyberknife

Eligibility

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

Sponsor

Capital Health System, Inc

Source: Clinicaltrials.gov

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