Oligomets pancreas SBRT


About this study

The primary endpoint for this study will compare PFS between SBRT + standard chemotherapy vs. standard chemotherapy alone in patients with oligometastatic pancreatic cancer. PFS is defined as the time from randomization to the first of either disease progression or death from any cause, where disease progression will be determined based on RECIST 1.1 criteria and will be documented at each enrolling site with no central review planned.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age ≥ 18 years old.
  • Histologically confirmed adenocarcinoma of pancreatic origin with pathologic material reviewed by the Department of Pathology at Mayo Clinic.
  • 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 cfDNA, and positive peritoneal biopsy would be considered ineligible).
  • Measurable disease as defined by RECIST criteria.
  • 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.
  • 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.
  • Have been treated with systemic therapy with standard chemotherapy regimens (FOLFIRINOX or Gemcitabine/nab-Paclitaxel or gemcitabine-doublet) with documented at least stable disease (by RECIST1.1 imaging criteria), for at least 4 months prior to study enrollment.
  • The following laboratory values obtained ≤ 14 days prior to registration:
    • Hemoglobin ≥ 9.0 g/dL;
    • Absolute neutrophil count (ANC) ≥ 1500/mm^3;
    • Platelet count ≥ 100,000/mm^3;
    • Total bilirubin ≤ 1.5 x ULN (If known Gilbert’s syndrome, then ≤ 3.0 x ULN);
    • Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement);
    • PT/INR/aPTT ≤ 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy;
    • Calculated creatinine clearance ≥ 45 ml/min using the Cockcroft-Gault formula below:
    • Cockcroft-Gault Equation:
    • Creatinine clearance for males =      (140 - age)(weight in kg)
    •                                                           ( 72)(serum creatinine in mg/dL)
    • Creatinine clearance for females =   (140 - age)(weight in kg)(0.85)
    •                                                           (72)(serum creatinine in mg/dL)

Exclusion Criteria:

  • 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.
  • 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Michael Rutenberg, M.D., Ph.D.

Open for enrollment

Contact information:

Jacquelyn Gardner M.B.A.


More information


Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions