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Trial Title:
Stereotactic Adaptive Radiation Therapy of Borderline Resectable Pancreatic Cancer an Individualized Approach
NCT ID:
NCT05764720
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Daily Adaptive External Beam Radiation Therapy
Description:
Daily adaptive external beam radiation therapy delivered on Varian Ethos treatment
system.
Arm group label:
Daily Adaptive External Beam Radiation Therapy
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Washington University, St. Louis
Address:
City:
Saint Louis
Zip:
63130
Country:
United States
Status:
Recruiting
Contact:
Last name:
Hyun Kim, MD
Start date:
May 14, 2023
Completion date:
February 15, 2027
Lead sponsor:
Agency:
Varian, a Siemens Healthineers Company
Agency class:
Industry
Collaborator:
Agency:
Washington University School of Medicine
Agency class:
Other
Source:
Varian, a Siemens Healthineers Company
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05764720
