Recruiting

Cyberknife

Sponsor:

Capital Health System, Inc

Code:

NCT04998552

Conditions

Pancreas Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cyberknife

Study Details

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

Study ID

NCT04998552

Start date

Jun 22, 2021

Status verified date

Mar, 2023

Completion date

Jun 22, 2027

Anticipated

Primary completion date

Jun 22, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: SBRT (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).

Interventions

Cyberknife

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

Primary outcome measure

  • Resectability [ Time Frame: 1 month after the completion of radiation therapy. ]

Central Contacts and Locations

Central contacts

Shirnett Williamson, MD

609-303-4244swilliamson@capitalhealth.org

Locations

Capital Health Medical Center-Hopewell

Recruiting

Pennington, New Jersey, United States, 08534

Contacts

Patrick DeDeyne, PhD

609-394-4130pdedeyne@capitalhealth.org

More Information

Sponsor

Capital Health System, Inc

Last update posted

Mar 31, 2023

Last verified

Mar, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Capital Health System, Inc on 2023-03-31.