Effects of Folfirinox and Stereotactic Body Radiation Therapy for Advanced Pancreatic Cancer

• Status: Recruiting
• Trial end date: 2025-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study wants to find out how safe and effective the use of Folfirinox combined with Stereotactic Body Radiation Therapy )(SBRT) is for the treatment of pancreatic cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: James Graham Brown Cancer Center; University of Louisville
• Collaborators: James Graham Brown Cancer Center; University of Louisville
• Treatments: Fluorouracil; Folfirinox; Irinotecan; Leucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

• Age >/= 18 years

• ECOG performance status 0-1

• Pathologic or clinical diagnosis of a new pancreatic adenocarcinoma. A reasonable attempt should be made to make a pathologic diagnosis of malignancy.

• Imaging as follows:

• CT scan of the chest, abdomen and pelvis with IV and oral contrast within 8 weeks of registration

• Whole body PET scan within 8 weeks of registration

• Evaluation by a surgical oncologist to determine non-resectability

• Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential.

• CBC/differential obtained within 14 days prior to registration with adequate bone marrow function as follows:

• ANC > 1,500 cell/mm3

• Platelets > 100,000 cells/mm3

• Hemoglobin > 8.0 g/dl (transfusion to obtain this value is permissible)

• Additional labs within 14 days prior to registration

• CA 19-9

• Creatinine <2mg/dl

• Bilirubin <2mg/dl

• AST and ALT < 2.5 x ULN

• Patients must provide study specific informed consent prior to study entry.

Exclusion Criteria:

• Metastatic disease as defined by the multi-disciplinary team

• Prior anti-cancer therapy for a pancreatic tumor

• Prior malignancy within the last 3 years.

• Pregnant women or lactating women

• Acquired Immune Deficiency Syndrome (AIDS) based on CDC criteria. However HIV testing is not manditory for this protocol

• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects