NCT04998552

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Capital Health System, Inc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Pancreas Adenocarcinoma

Interventions

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

Timeline

• Start date: 2021-06-22
• Primary completion: 2027-06-22
• Completion: 2027-06-22
• First posted: 2021-08-10
• Last updated: 2023-03-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study