EXtending outcomes for PAncreas cancer patients with Nominal oligometastatic Disease (EXPAND): A Randomized Phase III Trial

This study is a randomized phase III trial looking at new treatment options for people with pancreatic cancer that has spread to only a few places in the body (called oligometastatic disease, meaning five or fewer spots of spread).

The goal of the study is to see if adding metastasis-directed therapy (MDT)—such as focused radiation, surgery, or ablation—to all known tumor sites, along with standard cancer medicines (systemic therapy), helps patients live longer without their cancer getting worse. We will compare this approach to systemic therapy alone, which is the current standard treatment.

In order to participate you must meet the following criteria:

• Are 18 years of age or older.
• Have histologically or cytologically confirmed pancreatic ductal adenocarcinoma.
• Are between one and five distant metastatic lesions.
• Females of childbearing potential must not be breast feeding and must have a negative serum or urine pregnancy test.

You will be excluded from the study if any of the following criteria apply to you:

• Have metastatic effusion (e.g. pleural effusion or ascites). Note that patients with an effusion that is too small to sample will be eligible for the trial.
• Have leptomeningeal disease.
• Have peritoneal carcinomatosis.
• Are cognitively impaired. (e.g. Inability to sign informed consent.)
• Have any condition that, in the opinion of the investigator, would interfere with the study treatment or interpretation of the study results.
• Have diffuse bone marrow involvement as defined by disease involvement of a BM biopsy from a site that does not have radiologic evidence of a bone metastasis.
• Have more than 4 prior lines of systemic therapy to treat metastatic disease.
• Have a diagnosis of active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe delivery of radiotherapy. Such patients may be eligible if dispositioned to non-radiotherapy MDT.
• Have a known psychiatric or substance abuse disorder/s that would interfere with trial participation.
• Have concurrent (synchronous or metachronous) other primary malignancy that in the opinion of the treating physician team presents a substantial risk to the patient’s life as a competing risk of death (against the primary oligometastatic pancreatic cancer being considered for MDT as part of this trial).

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.