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Clinical Trial Record

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

2023-05-14

2026-02-15

2028-02-15

134

Study Overview

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

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.

N/A

  • Pancreatic Cancer
  • RADIATION: Daily Adaptive External Beam Radiation Therapy
  • VAR-2021-07

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2023-02-13  

N/A  

2025-07-17  

2023-03-07  

N/A  

2025-07-23  

2023-03-13  

N/A  

2025-07  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/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.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Acute Grade 3+ treatment related GI toxicitiesThe rate of acute Grade 3 or higher treatment related GI toxicities using CTCAE version 5.0 criteriaWithin 90 days from start of treatment
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Long Term Grade 3+ treatment related GI toxicitiesThe rate of long term Grade 3 or higher treatment related GI toxicities, using CTCAE version 5.0 criteria12 months after completion of external beam radiation treatment
Overall SurvivalKaplan-Meier estimates of the rates of overall survivalOne and two years after completion of external beam radiation treatment
Local in-field ControlLocal (in-field) control rates defined as stable disease, partial response, or complete response by RECIST criteriaOne and two years after completion of external beam radiation treatment
Progression Free SurvivalKaplan-Meier estimates of distant-progression-free survivalOne and two years after completion of external beam radiation treatment

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Jennifer Woo

Phone Number: 437-991-3496

Email: jennifer.woo@varian.com

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Washington University School of Medicine
  • PRINCIPAL_INVESTIGATOR: Lauren Henke, MD, Case Western Reserve University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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