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

NCT05764720 | Recruiting FDA Device

• 1 other identifier: VAR-2021-07
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Long Term Grade 3+ treatment related GI toxicities

  12 months after completion of external beam radiation treatment

• Overall Survival

  One and two years after completion of external beam radiation treatment

• Local in-field Control

  One and two years after completion of external beam radiation treatment

• Progression Free Survival

  One and two years after completion of external beam radiation treatment

Study Arms (1)

Daily Adaptive External Beam Radiation Therapy

EXPERIMENTAL

Daily adaptive radiation therapy delivered with Varian Ethos treatment system

Radiation: Daily Adaptive External Beam Radiation Therapy

Interventions

Daily Adaptive External Beam Radiation Therapy RADIATION

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

Daily Adaptive External Beam Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed borderline-resectable (based on NCCN criteria), locally-advanced (based on NCCN criteria), or medically inoperable pancreatic adenocarcinoma.
• ECOG performance status 0-1
• 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.
• 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.
• At least 18 years of age.
• 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).
• 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.
• 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.
• Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

You may not qualify if:

• Past history of radiotherapy within the projected treatment field
• Prior, intercurrent, or planned receipt (within 90 days prior to or following SBRT) of any investigational agents related to pancreatic cancer diagnosis.
• Competing, active cancer diagnosis within the preceding one year.
• 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.
• Gross tumor invasion of the stomach or duodenum (defined either radiographically or endoscopically).
• Pregnant and/or breastfeeding. Patients of childbearing potential must have a negative pregnancy test within 14 days of study entry.

Sponsors & Collaborators

• Washington University School of Medicine: collaborator
• Varian, a Siemens Healthineers Company: lead

Study Sites (3)

University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

RECRUITING

Washington University, St. Louis

St Louis, Missouri, 63130, United States

RECRUITING

UH Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Lauren Henke, MD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kate Campbell

CONTACT

206-218-8173; kate.campbell@varian.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: March 13, 2023
• Study Start: May 14, 2023
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 15, 2030
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)