Pancreatic CancerARTIA-PancreasNCT05764720
Stereotactic Adaptive Radiation Therapy of Borderline Resectable Pancreatic Cancer an Individualized Approach
A study testing Daily Adaptive External Beam Radiation Therapy in people with Pancreatic Cancer, run by Varian, a Siemens Healthineers Company at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Daily Adaptive External Beam Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 May 2023to 15 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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).
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35205
Gobind Gill, MD, 205-996-1087, gsgill@uabmc.edu
Gobind Gill, MD
- Recruiting
UH Cleveland Medical Center
Cleveland, Ohio, 44106
Lauren Henke, MD, 218-234-6429, lauren.henke@uhhospitals.org
Lauren Henke, MD
- Recruiting
City of Hope
Duarte, California, 91010
Yufei Liu, MD PhD, 626-218-4403, yufliu@coh.org
Yufei Liu, MD PhD
- Recruiting
Washington University, St. Louis
St Louis, Missouri, 63130
Michael Waters, MD PhD, 571-232-8050, m.r.waters@wustl.edu
Michael Waters, MD PhD
About this study
Official title: 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 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
- Being tested
- Daily Adaptive External Beam Radiation Therapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily Adaptive External Beam Radiation TherapyRadiation
Daily adaptive external beam radiation therapy delivered on Varian Ethos treatment system.
| Study group | Role | What they receive |
|---|---|---|
| Daily Adaptive External Beam Radiation Therapy | Experimental | Daily adaptive radiation therapy delivered with Varian Ethos treatment system Receives: Radiation: Daily Adaptive External Beam Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 90 days from start of treatment
Secondary outcomes (4)
Long Term Grade 3+ treatment related GI toxicities
The rate of long term Grade 3 or higher treatment related GI toxicities, using CTCAE version 5.0 criteria
Measured: 12 months after completion of external beam radiation treatment
Overall Survival
Kaplan-Meier estimates of the rates of overall survival
Measured: One and two years after completion of external beam radiation treatment
Local in-field Control
Local (in-field) control rates defined as stable disease, partial response, or complete response by RECIST criteria
Measured: One and two years after completion of external beam radiation treatment
Progression Free Survival
Kaplan-Meier estimates of distant-progression-free survival
Measured: One and two years after completion of external beam radiation treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start14 May 2023
- Primary completionMar 2028 (estimated)
- Study completion15 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Varian, a Siemens Healthineers CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Varian, a Siemens Healthineers Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Washington University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Lauren Henke, MD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764720
- Sponsor's protocol ID
- VAR-2021-07
- Acronym
- ARTIA-Pancreas
- Status last verified
- Sep 2026
- First submitted
- 13 Feb 2023
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Henke LE, Kim H, Laugeman E, Kohlmyer S, McCann C, Pietrovito K, Russell K, Woo J, Price AT. Stereotactic Adaptive Radiation Therapy for Borderline Resectable or Locally Advanced Pancreatic Cancer to Minimize Gastrointestinal Toxicity (ARTIA-Pancreas): Protocol for a Single-Arm Prospective Trial. JMIR Res Protoc. 2026 Feb 23;15:e84607. doi: 10.2196/84607.
PubMed 41730182
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial of Stereotactic Adaptive Radiation Therapy for Borderline Resectable/Locally Advanced Pancreatic Cancer: An Individualized Approach to Minimizing Gastrointestinal Toxicity (ARTIA-Pancreas)
- ClinicalTrials.gov ID
- NCT05764720
- Acronym / sponsor ID
- ARTIA-Pancreas / VAR-2021-07
- Conditions
- Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Varian, a Siemens Healthineers CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Washington University School of Medicine
- Study start
- 14 May 2023 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- 15 Mar 2030 (estimated)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daily Adaptive External Beam Radiation Therapy | Experimental | Radiation: Daily Adaptive External Beam Radiation TherapyDaily adaptive radiation therapy delivered with Varian Ethos treatment system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily Adaptive External Beam Radiation TherapyDaily adaptive external beam radiation therapy delivered on Varian Ethos treatment system. | Radiation | Daily Adaptive External Beam Radiation Therapy |
Primary outcome
Acute Grade 3+ treatment related GI toxicities
Time frame: Within 90 days from start of treatment
The rate of acute Grade 3 or higher treatment related GI toxicities using CTCAE version 5.0 criteria
4 secondary outcomes
Long Term Grade 3+ treatment related GI toxicities
Time frame: 12 months after completion of external beam radiation treatment
Overall Survival
Time frame: One and two years after completion of external beam radiation treatment
Local in-field Control
Time frame: One and two years after completion of external beam radiation treatment
Progression Free Survival
Time frame: One and two years after completion of external beam radiation treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Derived from this study: PubMed 41730182Henke LE, Kim H, Laugeman E, Kohlmyer S, McCann C, Pietrovito K, Russell K, Woo J, Price AT. Stereotactic Adaptive Radiation Therapy for Borderline Resectable or Locally Advanced Pancreatic Cancer to Minimize Gastrointestinal Toxicity (ARTIA-Pancreas): Protocol for a Single-Arm Prospective Trial. JMIR Res Protoc. 2026 Feb 23;15:e84607. doi: 10.2196/84607.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lauren Henke, MD principal investigator
Case Western Reserve University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily Adaptive External Beam Radiation Therapy in people with Pancreatic Cancer, run by Varian, a Siemens Healthineers Company at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kate Campbell (206-218-8173, kate.campbell@varian.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Grade 3+ treatment related GI toxicities (time frame: Within 90 days from start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05764720, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.