NCT03704662
Preoperative Fractionated Radiation Therapy Versus Stereotactic Body Radiation Therapy for Resectable or Borderline Resectable, or Locally Advanced Type A Pancreatic Adenocarcinoma
Active, Not Recruiting
NAAges 18+InterventionalTreatmentMedical College of WisconsinInvestigator-initiated
~102 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:Stereotactic Body Radiation TherapyPreoperative Fractionated Radiation Therapy and Chemotherapy
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The number of subjects who present with node-positive disease following surgical resection.
Measured over 8 weeks postradiation
Conditions
Where it's being run
1 sites across 1 statesWisconsin1
Study leadership
- William Hall, MD · PRINCIPAL_INVESTIGATOR · Medical College of Wisconsin
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3
Platelets ≥100,000 cells/mm3 (see section 4)
Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.)
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 4 x upper limit of normal
Total bilirubin \< 1.5 x upper normal mg/dL
Alkaline phosphatase \< 4 x upper limit of normal 11. Not on hemodialysis. 12. Negative serum pregnancy test (if applicable). 13. Ability to swallow oral medications. 14. Patients must have had at least one cycle of systemic chemotherapy without evidence of distant progression. 15. Patient must provide study-specific informed consent prior to study entry. 16. Women of childbearing potential and male participants who are sexually active must practice adequate contraception.
Exclusion
Unstable angina and/or congestive heart failure requiring hospitalization within the last six months.
Transmural myocardial infarction within three months prior to study entry.
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration.
Uncontrolled malabsorption syndrome significantly affecting gastrointestinal function.
Any unresolved bowel or bile duct obstruction.
Major resection of the stomach or small bowel that could affect the absorption of capecitabine.
Acquired immune deficiency syndrome (AIDS), based upon current Center for Disease Control (CDC) definition. Note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because patients receiving antiretroviral therapy may experience possible pharmacokinetic interactions with capecitabine.
Absence of any significant medical comorbidity which would preclude the consideration of major pancreatic surgery. 6. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception during the course of the study and for women three months after study therapy is completed and for men six months after study therapy is completed. This exclusion is necessary because the treatment involved in this study may be significantly teratogenic. 7. Women who are lactating at the time of registration and who plan to be lactating through three months after study therapy is completed. 8. Prior allergic reaction to capecitabine or gemcitabine. 9. Participation in another interventional clinical treatment trial while on study (observational trials are permitted). 10. Patients taking nonprotocol-specified chemotherapy agents or immune modulating agents for other medical conditions are not permitted to participate in this trial. Any medication questions should be reviewed by the PI.
What this trial measures
- The number of subjects who present with node-positive disease following surgical resection.8 weeks postradiation
Subjects will undergo surgical resection within three to eight weeks following treatment.