Surgical Resection of Synchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma

• Status: Not yet recruiting
• Trial end date: 2028-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase II, Open-Label, Single Arm trial investigating the outcomes of neoadjuvant FOLFIRINOX chemotherapy in patients with hepatic or pulmonary oligometastatic pancreatic adenocarcinoma.

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

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Treatments: Folfirinox

Criteria

Inclusion Criteria:

1. Histologically confirmed diagnosis of treatment-naïve limited hepatic or pulmonary metastatic adenocarcinoma of the pancreas

2. Meet the definition of limited hepatic or pulmonary metastasis according to CT/MRI that is done prior to the starting of any anticancer treatment. Either CT scan of chest, abdomen, and pelvis with intravenous contrast or a combination of MRI of abdomen and pelvis and CT scan of chest is acceptable radiographic imaging. CT/MRI can be done at an outside facility, but must be reviewed by a Johns Hopkins Medicine radiologist.

3. Measurable disease according to RECIST v1.1

4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1

5. Being a candidate for the chemotherapy with FOLFIRINOX or modified FOLFIRINOX

6. Patients ≥18 years at the time of signing the informed consent

7. Patient's written informed consent prior to any trial-specific procedure

8. Patient's legal capacity to consent to participation in the clinical trial

Exclusion Criteria:

1. Acinar cell carcinoma and/or neuroendocrine carcinoma of the pancreas

2. Symptomatic clinically significant ascites

3. Evidence of any distant metastases other than limited hepatic or pulmonary metastasis as defined in inclusion criterion 1.

4. Evidence of simultaneous pulmonary and hepatic metastases

5. Any tumor-specific pretreatment of the adenocarcinoma of the pancreas (including but not limited to surgery, radiation therapy, chemotherapy or ablative procedures). Currently being on FOLFIRINOX or modified FOLFIRINOX (mFOLFIRINOX) is allowed, unless more than 2 treatments of FOLFIRINOX or mFOLFIRINOX has been given.

6. Any malignancies other than adenocarcinoma of the pancreas in the 2 years before the start of the clinical trial except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, breast cancer, prostate cancer or superficial bladder tumors (Ta, Tis and T1)

7. Known HIV seropositivity

8. Known active or chronic Hepatitis B or Hepatitis C infection

9. Any other severe concomitant disease or disorder, which could influence patient's ability to participate in the clinical trial and his/her safety during the trial or interfere with interpretation of results, e.g., severe hepatic, renal, pulmonary, cardiovascular, metabolic or psychiatric disorders