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

Part of paid clinical trials in Pennington, New Jersey.

Sponsor
Capital Health System, Inc
Study ID
NCT04998552
Status
Recruiting
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Conditions

  • Pancreas Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 Dates

Start date
Jun 22, 2021
Status verified
Mar 2023
Primary completion
Jun 22, 2027
Completion
Jun 22, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

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).

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Capital Health Medical Center-HopewellPenningtonNew Jersey08534
Patrick DeDeyne, PhD
[email protected]
609-394-4130

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By research site
Capital Health Medical Center-Hopewell· Pennington, NJ

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