Stereotactic Adaptive Radiation Therapy of Borderline Resectable Pancreatic Cancer an Individualized Approach

Description

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.

Conditions

Pancreatic Cancer

Study Overview

Study Details

Study overview

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.

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

Stereotactic Adaptive Radiation Therapy of Borderline Resectable Pancreatic Cancer an Individualized Approach

Condition
Pancreatic Cancer
Intervention / Treatment

-

Contacts and Locations

Saint Louis

Washington University, St. Louis, Saint Louis, Missouri, United States, 63130

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Varian, a Siemens Healthineers Company,

Lauren Henke, MD, PRINCIPAL_INVESTIGATOR, Case Western Reserve University

Study Record Dates

2028-02-15