AzTrials
AzTrials

Metastatic Pancreatic AdenocarcinomaPhase 2NCT04975516

Standard of Care Chemotherapy With or Without Stereotactic Body Radiation Therapy for Oligometastatic Pancreatic Cancer

A Phase 2 study testing Chemotherapy, Stereotactic Body Radiation Therapy and Computed Tomography in people with Metastatic Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8, run by Mayo Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This phase II trial studies the effect of standard of care chemotherapy with or with out stereotactic body radiation therapy in treating patients with pancreatic cancer that has spread to a limited amount of places in the body (oligometastatic). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Chemotherapy, Stereotactic Body Radiation Therapy and Computed Tomography
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
18 Jul 2023to 15 Nov 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Age >= 18 years
  • Histologically confirmed adenocarcinoma of pancreatic origin with pathologic material reviewed by the Department of Pathology at Mayo Clinic, if available and applicable
  • Image proven oligometastatic pancreatic cancer patients (i.e., synchronous \& metachronous)
  • Oligometastatic defined as: =< 5 extracranial metastatic tumors (brain metastasis patients are excluded; indeterminate lung nodules stable on 2 consecutive imaging studies spaced more than 4 weeks apart will not count as sites of oligometastatic disease)
  • All sites must be amenable to SBRT (positive peritoneal washings cytology or Kras cell free (cf)DNA, and positive peritoneal biopsy would be considered ineligible)
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Show all 22Show fewer
  • Non-measurable disease
  • NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease; disease that is measurable by physical examination only is not eligible
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
  • Negative pregnancy test done =< 7days prior to registration, for women of childbearing potential only
  • NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  • Ability to complete questionnaire(s) by themselves or with assistance
  • Provide written informed consent
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
  • Willing to provide tissue and/or blood samples for correlative research purposes
  • Hemoglobin >= 9.0 g/dL (obtained =< 28 days prior to registration)
  • Absolute neutrophil count (ANC) >= 1500/mm^3 (obtained =< 28 days prior to registration)
  • Platelet count >= 100,000/mm^3 (obtained =< 28 days prior to registration)
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) (If known Gilbert's syndrome, then =< 3.0 x ULN) (obtained =< 28 days prior to registration)
  • Alanine aminotransferase (ALT) and aspartate transaminase (AST) =< 3 x ULN (=< 5 x ULN for patients with liver involvement) (obtained =< 28 days prior to registration)
  • Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) =< 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy (obtained =< 28 days prior to registration)
  • Calculated creatinine clearance >= 45 ml/min using the Cockcroft-Gault formula (obtained =< 28 days prior to registration)

Who cannot join

  • Pregnant women
  • Nursing women
  • Men or women of childbearing potential who are unwilling to employ adequate contraception
  • Any of the following prior therapies:
  • Surgery =< 3 weeks prior to registration
  • Prior radiation to an overlapping area
Show all 18Show fewer
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • 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
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
  • Other active malignancy =< 1 year prior to registration
  • EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix
  • NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer
  • History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

Other trials in United States

About this study

Official title: Phase 2 Randomized Trial of Standard of Care Chemotherapy With or Without Stereotactic Body Radiation Therapy for the Treatment of Oligometastatic Pancreatic Adenocarcinoma

This phase II trial studies the effect of standard of care chemotherapy with or with out stereotactic body radiation therapy in treating patients with pancreatic cancer that has spread to a limited amount of places in the body (oligometastatic). Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with stereotactic body radiation therapy may help improve tumor control, decrease risk of tumor spreading more, decrease side effects, and prolong survival.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Compare progression free survival (PFS) between stereotactic body radiation therapy (SBRT) + standard chemotherapy versus (vs.) standard chemotherapy alone in patients with oligometastatic pancreatic cancer.

SECONDARY OBJECTIVES:

  1. Confirmed response rate. II. Overall survival. III. Adverse events. IV. Longitudinal assessment of circulating tumor cells (CTC) and circulating tumor deoxyribonucleic acid (ctDNA).

CORRELATIVE RESEARCH OBJECTIVE:

  1. To evaluate fatigue, and other patient-reported outcomes.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients undergo SBRT once daily (QD) or every other day for 5 fractions and receive chemotherapy per standard of care on study. Additionally, patients undergo computed tomography (CT), magnetic resonance imaging (MRI), and blood collection throughout the study.

GROUP II: Patients receive chemotherapy per standard of care on study. Additionally, patients undergo CT, MRI, and blood collection throughout the study. Patients who have local disease progression at known sites and no new sites of progression may crossover to the radiotherapy arm.

After completion of study treatment, patients are followed up at 7 and 14 days, and then every 8-12 weeks for 2 years.

Being tested
Chemotherapy, Stereotactic Body Radiation Therapy, Computed Tomography, Magnetic Resonance Imaging, Biospecimen Collection
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChemotherapyDrug

    Also called Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, General

    Given chemotherapy

  • Stereotactic Body Radiation TherapyRadiation

    Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

    Undergo SBRT

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, computerized axial tomography

    Undergo CT

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance Imaging (MRI), MRI, Magnetic Resonance / Nuclear Magnetic Resonance, MRI Scan

    Undergo MRI

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood collection

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT04975516
Study groupRoleWhat they receive
Group I (SBRT, chemotherapy)ExperimentalPatients undergo SBRT QD or every other day for 5 fractions, and receive chemotherapy per standard of care.
Receives: Drug: Chemotherapy; Radiation: Stereotactic Body Radiation Therapy; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Biospecimen Collection; Other: Questionnaire Administration
Group II (chemotherapy)Active comparatorPatients receive chemotherapy per standard of care.
Receives: Drug: Chemotherapy; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Biospecimen Collection; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival

    Disease progression will be determined based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and will be documented at each enrolling site with no central review planned.

    Measured: Time from randomization to the first of either disease progression or death from any cause, assessed up to 2 years

Secondary outcomes (3)

  1. Confirmed Response Rate

    A patient will be classified as a confirmed response per the RECIST 1.1 criteria, if they have a partial or complete response for 2 consecutive evaluations at least 4 weeks apart. The proportion of patients with a confirmed response will be calculated and compared between the 2 arms using a Chi-square or Fisher's Exact test.

    Measured: Up to 2 years

  2. Overall Survival

    Will be estimated using the Kaplan-Meier method, where the log-rank test will be used to compare the 2 treatment arms.

    Measured: Time from study entry to death from any cause, assessed up to 2 years

  3. Incidence of Adverse Events

    The maximum grade for each type of adverse event will be summarized using Common Terminology Criteria for Adverse Events version 5.0. The frequency and percentage of grade 3+ adverse events will be compared between the 2 treatment arms. Comparisons between arms will be made by using either the Chi-square or Fisher's Exact test.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2021
  2. Study start18 Jul 2023
  3. Primary completion15 Nov 2025
  4. Study completion15 Nov 2025

Why it stopped: Low/slow accrual

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04975516
Sponsor's protocol ID
MC210711
Other IDs
NCI-2021-07006, 20-011610
Status last verified
May 2026
First submitted
14 Jul 2021
Last updated
18 Jun 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Elhariri A, Patel J, Mahadevia H, Modi K, Albelal D, Majeed U, Jones JC, Borad MJ, Tran NH, Rutenberg MS, Babiker H. Stereotactic body radiation therapy in oligometastatic pancreatic cancer: overall survival improvement and SMAD4 as a predictor of progression-free survival. J Gastrointest Oncol. 2025 Aug 30;16(4):1658-1666. doi: 10.21037/jgo-2025-100. Epub 2025 Aug 26.

    PubMed 40950337

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chemotherapy, Stereotactic Body Radiation Therapy and Computed Tomography in people with Metastatic Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8, run by Mayo Clinic at 1 site 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 22 inclusion and 18 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: stopped early, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (time frame: Time from randomization to the first of either disease progression or death from any cause, assessed up to 2 years). 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 NCT04975516, 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 18 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in