Recruiting

Stereotactic Adaptive Radiation Therapy

Sponsor:

Varian, a Siemens Healthineers Company

Code:

NCT05764720

Conditions

Pancreatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Daily Adaptive External Beam Radiation Therapy

Study Details

Brief summary:

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 ID

NCT05764720

Start date

May 14, 2023

Status verified date

Mar, 2026

Completion date

Mar 15, 2030

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

134 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Daily Adaptive External Beam Radiation Therapy

Daily adaptive radiation therapy delivered with Varian Ethos treatment system

Interventions

Daily Adaptive External Beam Radiation Therapy

Daily adaptive external beam radiation therapy delivered on Varian Ethos treatment system.

Primary outcome measure

  • Acute Grade 3+ treatment related GI toxicities [ Time Frame: Within 90 days from start of treatment ]

Central Contacts and Locations

Central contacts

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35205

Contacts

Principal Investigator:

Gobind Gill, MD

Washington University, St. Louis

Recruiting

St Louis, Missouri, United States, 63130

Contacts

Michael Waters, MD PhD

571-232-8050m.r.waters@wustl.edu

Principal Investigator:

Michael Waters, MD PhD

UH Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Principal Investigator:

Lauren Henke, MD

More Information

Sponsor

Varian, a Siemens Healthineers Company

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Varian, a Siemens Healthineers Company on 2026-03-16.