A Phase 2 interventional study of Chemotherapy and Stereotactic Body Radiation Therapy in Metastatic Pancreatic Adenocarcinoma, Stage IV Pancreatic Cancer AJCC v8 and Recurrent Pancreatic Adenocarcinoma, sponsored by Mayo Clinic. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by Mayo Clinic · Phase 2, Interventional, and Treatment
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.
PRIMARY OBJECTIVE:
I. 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:
I. 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:
I. 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.
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This study's enrollment of 2 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
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Image proven oligometastatic pancreatic cancer patients (i.e., synchronous \& metachronous)
Non-measurable disease
Negative pregnancy test done =\< 7days prior to registration, for women of childbearing potential only
Exclusion Criteria:
Any of the following prior therapies:
Uncontrolled intercurrent illness including, but not limited to:
Other active malignancy =\< 1 year prior to registration
Patients undergo SBRT QD or every other day for 5 fractions, and receive chemotherapy per standard of care.
Drug: Chemotherapy · Radiation: Stereotactic Body Radiation Therapy · Procedure: Computed Tomography · Procedure: Magnetic Resonance Imaging · Procedure: Biospecimen Collection · Other: Questionnaire Administration
Patients receive chemotherapy per standard of care.
Drug: Chemotherapy · Procedure: Computed Tomography · Procedure: Magnetic Resonance Imaging · Procedure: Biospecimen Collection · Other: Questionnaire Administration
Given chemotherapy
Also known as: Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, General
Undergo SBRT
Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Undergo CT
Also known as: CAT, CAT Scan, Computed Axial Tomography, computerized axial tomography, Computerized Tomography (CT) scan, CT, CT SCAN
Undergo MRI
Also known as: Magnetic Resonance Imaging (MRI), MRI, Magnetic Resonance / Nuclear Magnetic Resonance, MRI Scan, MRIs, NMRI, nuclear magnetic resonance imaging, sMRI, Structural MRI
Undergo blood collection
Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Ancillary studies
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.
Time frame: Time from randomization to the first of either disease progression or death from any cause, assessed up to 2 years
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.
Time frame: Up to 2 years
Overall Survival
Will be estimated using the Kaplan-Meier method, where the log-rank test will be used to compare the 2 treatment arms.
Time frame: Time from study entry to death from any cause, assessed up to 2 years
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.
Time frame: Up to 2 years
| Milestone | Group I (SBRT, Chemotherapy) | Group II (Chemotherapy) |
|---|---|---|
| Started | 1 | 1 |
| Completed | 1 | 0 |
| Not completed | 0 | 1 |
| Withdrew: Patient withdrawal prior to beginning treatment | 0 | 1 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Will be estimated using the Kaplan-Meier method, where the log-rank test will be used to compare the 2 treatment arms.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group I (SBRT, Chemotherapy) | — | — | — |
| Group II (Chemotherapy) | — | — | — |
Since only 1 patient received treatment and is included in the analysis population, their demographic information will not be reported to preserve anonymity.
| Age, Continuous | Group I (SBRT, Chemotherapy) | Group II (Chemotherapy) | Total |
|---|
| Sex: Female, Male | Group I (SBRT, Chemotherapy) | Group II (Chemotherapy) | Total |
|---|---|---|---|
| Female | — | — | — |
| Male | — | — | — |
| Ethnicity (NIH/OMB) | Group I (SBRT, Chemotherapy) | Group II (Chemotherapy) | Total |
|---|---|---|---|
| Hispanic or Latino | — | — | — |
| Not Hispanic or Latino | — | — | — |
| Unknown or Not Reported | — | — | — |
| Race (NIH/OMB) | Group I (SBRT, Chemotherapy) | Group II (Chemotherapy) | Total |
|---|---|---|---|
| American Indian or Alaska Native | — | — | — |
| Asian | — | — | — |
| Native Hawaiian or Other Pacific Islander | — | — | — |
| Black or African American | — | — | — |
| White | — | — | — |
| More than one race | — | — | — |
| Unknown or Not Reported | — | — | — |
| Region of Enrollment(participants) | Group I (SBRT, Chemotherapy) | Group II (Chemotherapy) | Total |
|---|
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