Surgical Resection of Synchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma

Perioperative Irinotecan Combined With Oxaliplatin and 5-Fluoracil/Folinic Acid (FOLFIRINOX) For Synchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma (PHOLIPANC): A Phase II, Open-Label, Single Arm Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Ductal Adenocarcinoma; Oligometastatic Disease
• Intervention / Treatment: Drug: FOLFIRINOX chemotherapy

Detailed Description

This clinical trial aims to evaluate the effectiveness and safety of neoadjuvant FOLFIRINOX chemotherapy in patients with hepatic or pulmonary oligometastatic pancreatic adenocarcinoma. FOLFIRINOX is administered in 14-day cycles following a specific treatment protocol. The primary goal is to assess treatment effectiveness, with secondary objectives including evaluating safety, impact on patients' health-related quality of life (HR-QoL), and analyzing the tumor microenvironment in organ-specific metastases of pancreatic cancer. An exploratory objective involves analyzing overall survival while considering HR-QoL in patients enrolled in a separate Institutional Review Board protocol for quality of life assessment.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jin He, MD, PhD; Phone Number: +1(410)614-7551; Email: jhe11@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital
      • Contact: Jin He, MD, PhD; Email: jhe11@jhmi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment arm; Eligible patients will undergo neoadjuvant FOLFIRINOX chemotherapy with the following order and dosing schedule: Irinotecan hydrochloride trihydrate is administered intravenously over approximately 90 minutes at a dose of 180 mg/m^2. Oxaliplatin is given intravenously over 2 hours at a dosage of 85 mg/m^2. 5-Fluorouracil is administered intravenously over approximately 46 hours at a dosage of 2400 mg/m^2. This treatment regimen is a modified FOLFIRINOX protocol.

Drug: FOLFIRINOX chemotherapy; Perioperative Irinotecan Combined with Oxaliplatin and 5-Fluoracil/Folinic Acid (FOLFIRINOX)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival after R0/R1 resection (OS-res) (only patients with R0/R1 resection)	To assess the efficacy of neoadjuvant FOLFIRINOX chemotherapy followed by R0/R1 resection in patients with hepatic or pulmonary oligometastatic adenocarcinoma of the pancreas	48 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
R0/R1 resection rate after neoadjuvant chemotherapy	Determine the rate of complete (R0) and near-complete (R1) tumor resections following neoadjuvant chemotherapy.	48 months
Overall Survival	Assess the overall survival of patients receiving neoadjuvant chemotherapy for pancreatic cancer.	48 months
Progression-Free Survival (PFS) after R0/R1 Resection (RECIST v1.1)	Analyze the progression-free survival (PFS) in patients who achieve R0/R1 resection status, as per the RECIST v1.1 criteria, following neoadjuvant chemotherapy.	48 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Related Quality of Life (HR-QoL) adjusted Overall Survival if enrolled in the separate Institutional Review Board protocol for QoL	Analyze the HR-QoL-adjusted overall survival if enrolled in the separate Institutional Review Board protocol for QoL	48 months

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Investigators: Principal Investigator: Jin He, MD, PhD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Estimated): March 25, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: November 2, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Irinotecan; Oxaliplatin; FOLFIRINOX
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Antineoplastic Agents; Folfirinox
• Other Study ID Numbers: J23143; IRB00414679 (Other Identifier: JHM IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No