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

NCT04998552 | Recruiting DMC FDA Device

• 1 other identifier: PANCAN SBRT
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• Resectability

  Occurrence of meeting resectability criteria using NCCN (PAN-C) guidelines

  1 month after the completion of radiation therapy.

Secondary Outcomes (2)

• Patient Reported Outcome (General) - European Organization for Research and Treatment of Cancer (EORTC).

  at baseline and then at 3 month intervals.

• Patient Reported Outcome (Specific)European Organization for Research and Treatment of Cancer (EORTC).

  At baseline and then at 3 month intervals.

Study Arms (2)

SBRT (Cyberknife)

EXPERIMENTAL

5-10 Gy/fraction. Average of 45 minutes every other day for a total of 5 sessions (1.5-2 weeks).

Radiation: Cyberknife

IMRT

ACTIVE COMPARATOR

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

Interventions

Cyberknife RADIATION

5-10 Gy/fraction.Average of 45 minutes every other day for a total of 5 sessions (1.5-2 weeks).

IMRT; SBRT (Cyberknife)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Capital Health System, Inc: lead

Study Sites (1)

Capital Health Medical Center-Hopewell

Pennington, New Jersey, 08534, United States

RECRUITING

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Shirnett Williamson, MD

  Capital Health System, Inc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shirnett Williamson, MD

CONTACT

609-303-4244; swilliamson@capitalhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is an open-label, longitudinal, prospective randomized, superiority clinical trial.

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: August 10, 2021
• Study Start: June 22, 2021
• Primary Completion (Estimated): June 22, 2027
• Study Completion (Estimated): June 22, 2027
• Last Updated: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)