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Table 1 Study calendar

From: A safety study of intraoperative radiation therapy following stereotactic body radiation therapy and multi-agent chemotherapy in the treatment of localized pancreatic adenocarcinoma: study protocol of a phase I trial

Week# (± days)

− 4–0

1 (± 7 days)

2 (± 14 days)

6 (± 28 days)

9 (± 21 days)

10 (± 21 days)

Q3mos (years 1–2) Q6mos (years 3–5)

Interventions/Procedures

EUS Fiducial placement

 

X

     

CT Simulation

 

X

     

SBRT × 5 days

  

X

    

Surgery

    

X

  

IORT (15 Gy/1 fraction)

    

X

  

Informed Consent

X

      

Inclusion/Exclusion Criteria

X

      

Demographics

X

      

Medical History

X

     

X

Medications

X

     

X

Vital Signs and Pulse Oximetry

X

     

X

Physical exam

X

     

X

Height

X

      

Weight

X

     

X

KPS

X

     

X

ECOG status

X

     

X

Pre-operative evaluation by surgery

   

X

   

Toxicity Assessment1

     

X^

X

Tests

       

Planning CT Abdomen2

     

X

 

Radiographic evaluation3

   

X

  

X

  1. EUS Endoscopic ultrasound, CT Computed tomography, SBRT Stereotactic body radiation therapy, IORT Intraoperative radiation therapy, KPS Karnofsky Performance Status, ECOG Eastern Cooperative Oncology Group, CTCAE Common Terminology Criteria for Adverse Events
  2. 1CTCAE v5.0 and Clavien-Dindo classification
  3. 2In Radiation Oncology department
  4. 3Diagnostic CT Abdomen
  5. ^Inpatient evaluation: post-operative hospitalization