The purpose of this study is to see if SBRT will be a better way to treat pancreas cancer and
to find out what effects, good and/or bad, this treatment will have on participants and their
Radiation: Stereotactic Body Radiation Therapy (SBRT)
Radiation: Tissue, Blood, Research Imaging (TBRI)
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01434550
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
All Participant inclusion criteria
Amenable to leukapheresis as determined by a leukapheresis nurse
Primary tumor that is accessible to direct intratumoral injection by CT-guidance confirmed by interventional radiologist
No history of autoimmune disease
No history of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) or other immunosuppressive diseases
No active viral or bacterial infection
No use of steroids or any other immunosuppressive drug at least 4 weeks prior to enrollment on study
Prior history of radiotherapy that overlaps with the planned ports to the primary pancreatic tumor
Patients with tumors that are not accessible to direct access cannot be included in the study.
Prior or concurrent chemotherapy
Prior history of antineoplastic therapy or irradiation
Prior treatment with anti-tumor vaccines not allowed
Patients with a history of autoimmune diseases
A history of HIV infection, AIDS or other immunosuppressive disease state. The need to exclude patients with HIV/AIDS is because one of the endpoints of the study is immune response. People with HIV have a compromised immune system and enrollment in this study could confound the results (TBRI only)
Patients requiring corticosteroids are ineligible because one of the endpoints of the study is immune response. Since steroids modulate the immune system, enrollment of patients on steroids could confound the results. There must be no use of corticosteroids in the fours weeks preceding entry into the study (TBRI only).
Active bacterial, fungal or viral infection
Active bleeding (hemoptysis, melena, etc.)
Women who are currently pregnant or actively breast feeding. Women of childbearing potential must have a negative serum pregnancy test and must use effective contraception during trial participation
Any medical or psychiatric illness which in the opinion of the principal investigator might compromise a patient's ability to tolerate or complete treatment
Any patient requiring blood thinners (due to risk of gastrointestinal [GI] bleed)
All locations for NCT01434550
View full eligibility
Tris trial is registered with FDA with number: NCT01434550. The sponsor of the trial is H. Lee Moffitt Cancer Center and Research Institute and it is looking for 0 volunteers for the current phase.
Official trial title: Phase II Study of First-line Stereotactic Body Radiation Therapy (SBRT) in Patients With Non-Metastatic Unresectable Pancreatic Cancer
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