Adaptive radiation therapy for borderline resectable pancreatic cancer

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 study is testing a new type of radiation therapy to see if it can effectively treat patients with hard-to-remove pancreatic cancer while causing less harm to their bodies.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 134 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Varian, a Siemens Healthineers Company (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 3 sites (Birmingham, Alabama and 2 other locations)
• Trial ID: NCT05764720 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of stereotactic adaptive radiation therapy to treat patients with borderline-resectable, locally-advanced, or medically inoperable pancreatic adenocarcinoma. It is a single-arm, prospective, multi-center trial that aims to deliver an ablative dose of radiation while minimizing toxicity. The study will assess gastrointestinal toxicity, overall survival rates, local control of the cancer, quality of life, and workflow metrics associated with the treatment.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with confirmed borderline-resectable or locally-advanced pancreatic adenocarcinoma who have undergone at least two months of chemotherapy.

Not a fit: Patients with resectable pancreatic cancer or those who cannot tolerate a break in systemic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved treatment outcomes and reduced side effects for patients with challenging pancreatic cancer cases.

How similar studies have performed: Other studies have shown promise with adaptive radiation therapy approaches, suggesting potential for success in this novel application.

Eligibility criteria

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.

Where this trial is running

Birmingham, Alabama and 2 other locations

• University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
• Washington University, St. Louis — St Louis, Missouri, United States (Recruiting)
• UH Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Lauren Henke, MD — Case Western Reserve University
• Study coordinator: Kate Campbell

Conditions Pancreatic Cancer