RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-06-22

Study Completion:2027-06-22

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04998552

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Shirnett Williamson, MD

CONTACT

609-303-4244

swilliamson@capitalhealth.org

Principal Investigator

Shirnett Williamson, MD

PRINCIPAL_INVESTIGATOR

Capital Health System, Inc

Study Locations (Sites)

Capital Health Medical Center-Hopewell

Pennington, New Jersey, 08534

United States

Collaborators and Investigators

Sponsor: Capital Health System, Inc

Shirnett Williamson, MD, PRINCIPAL_INVESTIGATOR, Capital Health System, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-22

Study Completion Date2027-06-22

Study Record Updates

Study Start Date2021-06-22

Study Completion Date2027-06-22

Terms related to this study

Additional Relevant MeSH Terms

Pancreas Adenocarcinoma