Stereotactic Adaptive Radiation Therapy of Borderline Resectable Pancreatic Cancer an Individualized Approach (ARTIA-Pancreas)

A Prospective Trial of Stereotactic Adaptive Radiation Therapy for Borderline Resectable/Locally Advanced Pancreatic Cancer: An Individualized Approach to Minimizing Gastrointestinal Toxicity (ARTIA-Pancreas)

This trial is a single-arm, prospective, multi-center clinical trial designed to demonstrate that stereotactic adaptive radiotherapy using an ablatively dosed (50Gy,5fx) for treatment of borderline-resectable, locally-advanced , or medically inoperable pancreatic adenocarcinoma will translate into a decreased toxicity. The study will evaluate GI toxicity, overall survival, local control, quality of life, and workflow metrics.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Radiation: Daily Adaptive External Beam Radiation Therapy

• Study Type: Interventional
• Enrollment (Estimated): 134
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kate Campbell; Phone Number: 206-218-8173; Email: kate.campbell@varian.com

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Recruiting
      • University of Alabama at Birmingham
      • Contact: Gobind Gill, MD; Phone Number: 205-996-1087; Email: gsgill@uabmc.edu
      • Principal Investigator: Gobind Gill, MD
  • Missouri
    • St Louis, Missouri, United States, 63130
      • Recruiting
      • Washington University, St. Louis
      • Contact: Michael Waters, MD PhD; Phone Number: 571-232-8050; Email: m.r.waters@wustl.edu
      • Principal Investigator: Michael Waters, MD PhD
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • UH Cleveland Medical Center
      • Principal Investigator: Lauren Henke, MD
      • Contact: Lauren Henke, MD; Phone Number: 218-234-6429; Email: lauren.henke@uhhospitals.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Histologically or cytologically confirmed borderline-resectable (based on NCCN criteria), locally-advanced (based on NCCN criteria), or medically inoperable pancreatic adenocarcinoma.
2. ECOG performance status 0-1
3. Receipt of at least two months of lead-in chemotherapy (regimen at the discretion of the treating physician) prior to planned initiation of CT-STAR.
4. Limited regional lymphadenopathy permitted. Node positive patients are restricted to those with up to 3 clinically involved (greater than 1cm on cross-sectional imaging or pathologically proven) nodes provided that the lymph nodes are adjacent to the primary tumor.
5. At least 18 years of age.
6. Must be able to take an interruption in systemic therapy at least one week prior to planned start of CT-STAR (two weeks preferred) lasting for the duration of CT-STAR and continuing for at least one week following end of CT-STAR (two weeks preferred).
7. Capable of a single end-exhale breath-hold of at least 20 seconds in duration and of repeated end-exhale or deep inspiratory breath-hold of at least 10 seconds in duration upon verbal instruction.

8. Anatomy of target and adjacent OARs adequately visualized on ETHOS simulation imaging, as determined by treating and study physicians.

   Note: central review of simulation imaging and initial plan target/OAR contours by the Principal Investigator and Physics lead is required for the first two patients at each participating institution prior to study treatment delivery. Patients with inadequate anatomic visualization at simulation will be considered screen-failures and treated off-protocol as per institutional standard-of-care.

9. Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

1. Past history of radiotherapy within the projected treatment field
2. Prior, intercurrent, or planned receipt (within 90 days prior to or following SBRT) of any investigational agents related to pancreatic cancer diagnosis.
3. Competing, active cancer diagnosis within the preceding one year.
4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
5. Gross tumor invasion of the stomach or duodenum (defined either radiographically or endoscopically).
6. Pregnant and/or breastfeeding. Patients of childbearing potential must have a negative pregnancy test within 14 days of study entry.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Daily Adaptive External Beam Radiation Therapy; Daily adaptive radiation therapy delivered with Varian Ethos treatment system	Radiation: Daily Adaptive External Beam Radiation Therapy; Daily adaptive external beam radiation therapy delivered on Varian Ethos treatment system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Grade 3+ treatment related GI toxicities	The rate of acute Grade 3 or higher treatment related GI toxicities using CTCAE version 5.0 criteria	Within 90 days from start of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long Term Grade 3+ treatment related GI toxicities	The rate of long term Grade 3 or higher treatment related GI toxicities, using CTCAE version 5.0 criteria	12 months after completion of external beam radiation treatment
Overall Survival	Kaplan-Meier estimates of the rates of overall survival	One and two years after completion of external beam radiation treatment
Local in-field Control	Local (in-field) control rates defined as stable disease, partial response, or complete response by RECIST criteria	One and two years after completion of external beam radiation treatment
Progression Free Survival	Kaplan-Meier estimates of distant-progression-free survival	One and two years after completion of external beam radiation treatment

Collaborators and Investigators

• Sponsor: Varian, a Siemens Healthineers Company
• Collaborators: Washington University School of Medicine
• Investigators: Principal Investigator: Lauren Henke, MD, Case Western Reserve University

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2023
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 15, 2030

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: March 7, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: VAR-2021-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No