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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreas Adenocarcinoma
• Intervention / Treatment: Radiation: Cyberknife

Detailed Description

The study is an open-label, longitudinal, prospective randomized, superiority clinical trial. The protocol applies to patients with confirmed diagnosis of pancreatic adenocarcinoma and pancreatic protocol CT scan showing borderline resectable disease or locally advanced disease as per the NCCN guidelines (See addendum, NCCN Guidelines 2021, PANC-3 and PANC-4). All cases will be discussed at the multidisciplinary GI cancer conference (tumor board). Cases will continue to be reviewed at different milestones of their treatment as described below.

Patients diagnosed with borderline resectable or locally advanced pancreatic cancer will receive standard of care and neoadjuvant chemotherapy according to NCCN guidelines and protocols followed by radiation therapy. The radiation therapy will start 4 weeks after ending the chemotherapy, thereby creating a wash-out period. At the start of the radiation therapy subjects will be consented and randomized into either receiving the IMRT protocol or the SBRT protocol. Baseline measurements will be collected at the start of the radiation treatment. At the completion of the radiation therapy the subject's progress and condition will be evaluated by the tumor board and a multidisciplinary consensus agreement will be reached to decide the course of further treatment, which could be chemotherapy (if deemed unresectable) or proceed with surgery (if deemed resectable). Irrespective the decision, patients will be asked to return for follow up every 3 months to obtain CT scans, assess quality of life and provide a biological sample (blood) for up to 12 months after the initiation of the radiation therapy.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shirnett Williamson, MD; Phone Number: 609-303-4244; Email: swilliamson@capitalhealth.org

Study Locations

• United States
  • New Jersey
    • Pennington, New Jersey, United States, 08534
      • Recruiting
      • Capital Health Medical Center-Hopewell
      • Contact: Patrick DeDeyne, PhD; Phone Number: 609-394-4130; Email: pdedeyne@capitalhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SBRT (Cyberknife); 5-10 Gy/fraction. Average of 45 minutes every other day for a total of 5 sessions (1.5-2 weeks).	Radiation: Cyberknife; 5-10 Gy/fraction.Average of 45 minutes every other day for a total of 5 sessions (1.5-2 weeks).
Active Comparator: IMRT; 1.2-3 Gy/fraction up to 40 fractions. 15 mins daily (M-F) for a total of 28 sessions (5.5 weeks).	Radiation: Cyberknife; 5-10 Gy/fraction.Average of 45 minutes every other day for a total of 5 sessions (1.5-2 weeks).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resectability	Occurrence of meeting resectability criteria using NCCN (PAN-C) guidelines	1 month after the completion of radiation therapy.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Outcome (General) - European Organization for Research and Treatment of Cancer (EORTC).	Change in mean score from baseline of Quality of Life using EORTC QLQ-C30 questionnaire. Raw score is transformed to standardize with a lowest value of 0 and a highest of 100.	at baseline and then at 3 month intervals.
Patient Reported Outcome (Specific)European Organization for Research and Treatment of Cancer (EORTC).	Change in mean score from baseline of Quality of Life using EORTC PAN26 questionnaire. Raw score is transformed to standardize with a lowest value of 0 and a highest of 100.	At baseline and then at 3 month intervals.

Collaborators and Investigators

• Sponsor: Capital Health System, Inc
• Investigators: Principal Investigator: Shirnett Williamson, MD, Capital Health System, Inc

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2021
• Primary Completion (Anticipated): June 22, 2027
• Study Completion (Anticipated): June 22, 2027

Study Registration Dates

• First Submitted: July 20, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 10, 2021

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: PANCAN SBRT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No