Safety of Cyberknife in Patients With Borderline Resectable or Locally Advanced Pancreatic Adenocarcinoma

Recruiting now · Not applicable

Conditions studied: Pancreas Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT04998552

Run by

Capital Health System, Inc

People needed

10

Starts

2021-06-22

Expected to finish

2027-06-22

Last updated by the study team

2023-03-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Capital Health Medical Center-Hopewell — Pennington, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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